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 Erythema (1840); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pocket Erosion (2013); Scar Tissue (2060); Seroma (2069); Impaired Healing (2378); Alteration in Body Temperature (4568); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8784, serial# (b)(4), product type: catheter, product id: 8782, serial# (b)(4), implanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 04-nov-2022, udi#: (b)(4).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 and a manufacturer representative (rep) regarding a patient receiving fentanyl 500 mcg for a total dose of 49.96747 mcg/day and bupivacaine 5 mg for a total dose of 0.49967 mg/day via an implantable pump.It was reported on (b)(6) 2021 the patient reported feeling nauseous and extremely tired.It was noted examination revealed the pump pocket appeared to be warm and red.The lumbar incision was swollen.Fluoroscopy on (b)(6) 2021 revealed 12 ml of sanguineous fluid.On (b)(6) 2021 it was noted that the pump pocket was clean, dry and intact and was within normal limits.It was noted the lumbar incision was within normal limits.On (b)(6) 2021 there was a large eschar in the middle of the pump pocket incision and swelling at the midline incision.Fluoroscopy revealed 0.5mls of sanguineous at the catheter and 22mls of sanguineous fluid over the pump pocket.Cultures/labs were sent and came back normal.The patient was referred to wound care.No action was taken.Samples were collected acellular and were sent for cultures.Additional information received reported on (b)(6) 2021 that the pump was exposed and contaminated.The pump and pump segment of the catheter were explanted/not replaced on (b)(6) 2021.It was noted the catheter was left in place for a future pump.Further information received indicated there was issues with healing properly at the pump pocket.There was no known factors that may have led or contributed to the event.The patient's medical history included chronic spinal pain.The patient's status at time of report was alive- no injury.The outcome was noted as ongoing.The clinical diagnosis was inflammation and possible infection at incision sites.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 unlikely related.The incisional site/device tract was pump pocket and lumbar site.The event date was (b)(6) 2021.No further complications were reported/anticipated.

Manufacturer Narrative

H3: the pump was returned, and analysis found anomaly.H3: the pump segment of the catheter (sn:(b)(6)) was returned, and analysis found no significant anomaly.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 2021-jun-23 the wound was still healing and was the size of a marble.On (b)(6) 2021, the patient was done at the wound clinic and healing was complete/wound was healed.The outcome of the event resolved without sequelae on (b)(6) 2021.

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.

Manufacturer Narrative

H3;the returned devices passed all testing in the laboratory and no significant anomalies were identified.Continuation of d10: product id 8784, serial# (b)(6), explanted: product type catheter product id 8782, serial# (b)(6), implanted: (b)(6) 2021, explanted: 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.

• 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: 11740528
• MDR Text Key: 264050671
• Report Number: 3004209178-2021-06865
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2023

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: 07/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 07/29/2021; 08/04/2021; 12/11/2023
• Supplement Dates FDA Received: 08/03/2021; 08/05/2021; 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female