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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Seroma (2069); Burning Sensation (2146); Neck Pain (2433)

Event Date 11/15/2021

Event Type  Injury  

Event Description

Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving an unknown drug (unknown dose and concentration) via an implantable pump for unknown indications for use.It was reported that on (b)(6) 2021 the patient called and reported status post oliff (oblique lateral interbody fusion) area around the pump was "so blown up they can't feel it"/patient reported fluid build up in pocket site and burning sensation in pocket when administering boluses.  on (b)(6) 2021 aspiration of the pump site occurred.  on (b)(6) 2021 a catheter access port contrast study was performed and the pump was intact and functional and found the catheter tip migrated from c2 to c6/7.  the patient declined revision.  csf sample taken from the pump pocket had glucose result of a 4.  csf sample from midline had a protein level of 123 on (b)(6) 2021.  the outcome was noted as ongoing.  the device diagnosis was catheter leakage and the clinical diagnosis was csf (cerebrospinal fluid) leak.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 not related.

Manufacturer Narrative

Concomitant medical products: product id: 8782, serial# (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 22-jun-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

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.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported on (b)(6) 2021 the hcp decided lab results to be inaccurate.However, if pump continued to fill with fluid, a revision may be required.On (b)(6) 2021, examination revealed the right and inferior aspect of incision was a 2 inch by 3 inch fluctuant swollen area.Zofran was prescribed on (b)(6) 2021.On (b)(6) 2021, the catheter revision was completed.It was determined that old catheter from previous surgery was still in place which caused a csf leak the clinical diagnosis was cerebrospinal fluid leak from preexisting catheter and the device diagnosis was updated to catheter dislodgement.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.

Manufacturer Narrative

H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 on (b)(6) 2021 the hcp decided lab results taken on (b)(6) 2021 to be inaccurate.However, if pump continued to fill with fluid, a revision may be required.On (b)(6) 2021 examination revealed the right and inferior aspect of incision was a 2 inch by 3 inch fluctuant swollen area.Zofran was prescribed on (b)(6) 2021.The outcome was noted as ongoing.The clinical diagnosis was cerebrospinal fluid leak from preexisting catheter.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.

Manufacturer Narrative

Continuation of d10: product id 8782 lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6)2021, 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 (hcp) via a clinical study reported that the affected catheter area was indicated to be the intrathecal/spinal portion.

Manufacturer Narrative

Continuation of d10: product id 8782, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type catheter.H6: patient code c50487 no longer applicable.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 reported the pump was used to deliver fentanyl 2000mcg//ml at 559.3mcg/day , bupivacaine 18.2mg/ml at 5.090mg/day and morphine 6.3mg/ml at 1.7618mg/day via an implantable pump.The other medications the patient was taking at the time of the event was vitamin d2 50,000 unit capsule, trazadone 100mg/ tablet, sertraline 100mg tablet, ondansetron 4mg disintegrating tablet, omeprazole 20mg capsule, methocarbamol 750mg tablet, hydroxyzine hcl 25mg/ml, bactrim ds 800-160mg tablet and aspirin 81mg.It was reported the patient had increased pain to his neck.There were no reported environmental, external or patient factors that may have led or contributed to the issue.The patient had a fusion surgery for low back pain unrelated to the tdd (targeted drug delivery) therapy.Post-surgery the patient developed a csf (cerebral spinal fluid) leak.Catheter dye study to check catheter to rule out any issues was normal but the catheter migrated from c2 to c6.The patient had surgery to replace the catheter and move back up to c two.The catheter did not appear to be the cause of the csf leak.Per the physician, the csf leak is related to previous surgery fusion.The issue was resolved at the time of the report and it was noted the healthcare provider would not have any furth er information regarding the event.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported on (b)(6) 2022 the patient reported ongoing headaches.

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

H3: the catheter was returned, and analysis found no significant anomaly (analysis identified an occlusion in the catheter body which is consistent with dried drug, blood or other foreign material).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 8782 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: (b)(6) 2021 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 was received from a healthcare provider via a clinical study indicated that the patient no longer had swelling at midline spinal incision.

• 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: 12865425
• MDR Text Key: 284709802
• Report Number: 3004209178-2021-17532
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 11/22/2021; 12/02/2021; 12/02/2021; 12/07/2021; 02/21/2022; 02/25/2022; 04/07/2022
• Supplement Dates FDA Received: 11/29/2021; 12/02/2021; 12/02/2021; 12/07/2021; 02/22/2022; 02/28/2022; 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 102 KG