MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Edema (1820); Erythema (1840); Unspecified Infection (1930); Pain (1994); Rash (2033); Complaint, Ill-Defined (2331); Impaired Healing (2378); Fluid Discharge (2686); Test Result (2695); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medial products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2013, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving fentanyl 2000 mcg for a total dose of 99.92952 mcg/day, bupivacaine 13 mg for a total dose of 0.64954 mg/day, and hydromorphone 3.7 mg for a total dose of 0.18487 mg/day via an implantable pump.It was reported on (b)(6) 2020 the patient presented with a rash around the pocket and lumbar wound areas/incisions post-surgery on (b)(6) 2020.It was noted the patient was still on post-operative antibiotics and they will monitor.On (b)(6) 2020 the incisions still present redness, but there was no concern for infection at this time.Post-operative antibiotics were extended.On (b)(6) 2020 examination revealed the pump pocket incision was starting to dry up and the medical edge was slightly dehisced.The midline incision was weeping at the superior edge.It was noted the patient continued on a another week of antibiotics and diflucan.On (b)(6) 2020 examination revealed the pump site looked better and a small area, more medial, was slightly dehisced.The midline incision continued to remain open and weeping.The patient was referred to wound clinic for consult.On (b)(6) 2020 the incisions were improving (superior edge of midline and medial edge pump pocket) with visit to wound clinic and was debrided.No surgery was needed at this time and no antibiotics were needed.The outcome of the event was noted as ongoing.The clinical diagnosis was pocket and lumbar wound dehiscence.The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was possibly related.The incisional site/device tract was pump pocket and lumbar site.The event date was (b)(6) 2020.Additional information received from a healthcare professional (hcp) via a clinical study reported there was no mention of a urinary tract infection (uti).An infection was not confirmed.Additional information received from a healthcare professional (hcp) via a clinical study reported on (b)(6) 2020 the patient reported the incision was healed.It was noted they fell about a week ago and the incision opened up again.It was noted that the incision was draining yellow fluid/yellow discharge.The incision was aspirated and cultures were sent.It was noted that aspiration and cultures were abnormal.On (b)(6) 2020 the patient was started on keflex and diflucan.Additional information was received from an hcp via a clinical study on (b)(6) 2020.It was reported that the infection was confirmed on (b)(6) 2020 and aspiration and cultures were abnormal.The exact date of the incision reopening was unknown.The clinical diagnosis was pocket and lumbar wound dehiscence with infection.No further complications were reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported examination on (b)(6) 2020 revealed a pump pocket infection - serratiam.It was noted the pump was reprogrammed on (b)(6) 2020 where the medication was decreased for surgery.No further complications were reported.

Manufacturer Narrative

H3: analysis of the pump revealed no anomaly.Analysis of the model 8784 catheter component with serial number (b)(6) revealed no significant anomaly; the catheter was returned in-complete / in segments.H6: the previously applied method code 4114 and results code 3221 remain applicable to the catheter components with serial number (b)(6) and serial number (b)(6).The method code 10 and results code 213 pertain to the pump and catheter component with serial number (b)(6).The conclusion code 67 remains applicable to the pump and all catheter components.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer and healthcare provider via a customer representative.As per provided healthcare provider notes, the patient chief complaint was lower back pain bilaterally on 2020- (b)(6).It was further reported that the patient experienced an infection at the pump pocket, and they explanted the entire device system.Culture results noted serratia marcescens.The patient rated her pain on 2020-(b)(6) at a level of 8/10 using the numeric pain intensity scale.The patient described the pain as aching, shooting, throbbing, stabbing, and sharp.The patientdenied any changes in her pain since their last visit.The patient denied new progressive neurological symptoms in the lower extremities.The patient denied any changes in the medications that she was prescribed outside of the healthcare provider¿s clinic.The patent denied any changes in their general health since their last visit.The patient was never a smoker and admitted to alcohol use at the equivalent of one drink socially.The patient had not had her testosterone or estrogen level drawn.The patient did not have any depression.The patient stated she sleeps normally and denied any history of sleep apnea.It was noted that the patient stated their level of physical activity had decreased.The p atient worked full time.The patient experienced an adverse event related to her pump.The patient reported a pocket infection on 2020-(b)(6).The patient admitted to edema and pain at the pocket site.The edema and pain at the pocket site were ongoing problems.The patient denied constipation, urinary difficulties, nausea, vomiting, excessive sweating, amenorrhea, excessive drowsiness, and changes in sexual dysfunction.The pump and complete catheter were to be returned to the manufacturer.The devices were to be replaced in the future.Environmental/external/patient factors that may have led or contributed to the issue was indicated as being unknown.It was unknown if the issue was resolved at the time of the report.The patient was without injury regarding their status as of 2020-(b)(6).It was noted that they reprogrammed and decreased 50%; decreased the personal therapy manager (ptm) to 6/day.As per the logs provided, the pump administered the following: fentanyl (concentration: 2000.0 mcg/ml, dose rate: decreased from 450 mcg/day to 225.0 mcg/day), bupivacaine (concentration; 13.0 mg/ml, dose rate: decreased from 2.925 mg/day to 1.463 mg/day), and h ydromorphone (concentration: 3.7 mg/ml, dose rate: decreased from 0.8326 mg/day to 0.4163 mg/day).Additional information was received from a healthcare provider via a clinical study on 2020-(b)(6).Regarding cultures collected the abnormal date of test was 2020-(b)(6).

Manufacturer Narrative

Continuation of d11: product id 8784 serial# (b)(6) implanted: 2020-(b)(6) explanted: 2020(b)(6) product type catheter product id 8782 serial# (b)(6) implanted: 2020(b)(6) explanted: 2020-(b)(6) product type catheter product id 8780 serial# (b)(6) implanted: 2013-(b)(6) explanted: 2020-(b)(6) product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(6), ubd: 2015-10-17, udi#: (b)(4); product id: 8784, serial/lot #: (b)(6), ubd: 2021-12-16, udi#: (b)(4); product id: 8784, serial/lot #: (b)(6), ubd: 2021-06-29, udi#: (b)(4) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis#: (b)(4): analysis information: on (b)(6) 2020 09:38:37 cst pli#: 10, product id#: 8637-40 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.The returned device passed all testing in the laboratory and no anomalies were identified.Continuation of d10: product id: 8784, lot#serial#: (b)(6); implanted: on (b)(6) 2020; explanted: on (b)(6) 2020; product type: catheter; product id: 8782; lot#serial#: (b)(6); implanted: on (b)(6) 2020; explanted: on (b)(6) 2020; product type: catheter; product id: 8780; lot#serial#: (b)(6); implanted: on (b)(6) 2013; explanted: on (b)(6) 2020; product type: catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information was received from an hcp via a clinical study.It was reported that on (b)(6) 2020 the incisions were still healing with no drainage.

Event Description

Additional information received from an hcp via a clinical study indicated that on (b)(6) 2020 the patient had developed swelling at the old pump site.35ml of pustulant fluid were aspirated from the pump pocket site guided by ultrasound, and the sample was sent out for cultures with positive growth noted.On (b)(6) 2020 the poorly healing scar over the pump pocket site was resected.Antibiotics were administered and irrigation, debridement, and primary closure of the pump pocket was performed.Cultures were submitted again.The event was ongoing.The etiology indicated the event was not related to the device/therapy and was unlikely related to the implant procedure.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported the results of the cultures taken on (b)(6) 2020 were abnormal.On (b)(6) 2020 the patient had no signs of infection at old pump sites.On (b)(6) 2021 the patient needed to be cleared from infections disease prior to implant (approximately february).No further complications were reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 8784 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type catheter product id 8782 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2020 product type catheter product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2013, explanted: (b)(6) 2020, product type catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported that the issue was resolved.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported that on (b)(6) 2020 the patient was prescribed 800-160mg bactrim ds (double strength) every 12 hours.The event was noted as resolved without sequelae on (b)(6) 2020.

Manufacturer Narrative

Continuation of d10: product id 8784, lot# , serial# (b)(6), implanted: (b)(6) 2020 explanted: (b)(6) 2020, product type catheter, product id 8782, serial# (b)(6), implanted: (b)(6)2020, explanted: (b)(6) 2020, product type catheter, product id 8780, serial# (b)(6), implanted: (b)(6) 2013,explanted: (b)(6) 2020, product type catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported the event resolved without sequelae on (b)(6) 2020.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 10305107
• MDR Text Key: 199830633
• Report Number: 3004209178-2020-12571
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 08/04/2020; 08/20/2020; 11/12/2020; 11/20/2020; 02/22/2021; 02/24/2021; 12/17/2021; 12/21/2021
• Supplement Dates FDA Received: 07/23/2020; 08/07/2020; 08/21/2020; 11/16/2020; 11/23/2020; 02/23/2021; 02/26/2021; 12/20/2021; 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 134 KG