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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Pocket Erosion (2013); Swelling (2091); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study on 2020-aug-03 regarding a patient receiving fentanyl (2000mcg/ml at 1001.21766mcg/day), hydromorphone (8mg/ml at 4.00487mg/day), and bupivacaine (20mg/ml at 10.01218mg/day) via an implanted infusion pump.It was reported that the patient reported pump pocket pain while sleeping.It was noted that the patient was active.Lidocaine patches and cushions were discussed, and the event was ongoing.The etiology indicated the event was related to the device/therapy and was not related to the implant procedure.No further complications were reported or anticipated.2020-aug-06 psr update (hcp, sdy): additional information was received from a healthcare provider via a clinical study.The pump was administering the following mediations: fentanyl (2000mcg/ml at 875.78547 mcg/day), hydromorphone (8mg/ml at 3.50314 mg/day), and b upivacaine (6.5 mg at 8.75785 mg/day).The pump dose rates were changed to the following: hydromorphone 3.49532 mg/day, fentanyl 1075.48381 mcg/day, and bupivacaine 8.76519 mg/day.Additional information was received from an hcp via a clinical study on 2020-sep-13.It was reported that on (b)(6) 2020, swelling was present around the pump pocket.There was no concern for infection and no skin break, so they continued to monitor.On (b)(6) 2020 the patient tore the skin over the pump pocket.It was noted that they were able to access without going through the tear.Due to the skin break down on the buttock, a new pump was to be implanted in the abdomen.

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 was received from the healthcare provider (hcp) via the manufacturer's representative (rep) on 2020-oct-22.It was reported that the patient's pump pocket had become irritated and had the potential to erode through the skin.The pump was repositioned to the abdomen at the replacement surgery.The issue was considered resolved at the time of the report.

Manufacturer Narrative

H3: the pump was returned, and analysis found corrosion and/or wear and/or lubrication and stall due to shaft bearing.H6: all previously reported method, result, and conclusion codes no longer apply to this event.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
• MDR Report Key: 10534767
• MDR Text Key: 206955246
• Report Number: 3004209178-2020-15944
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

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: 05/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: 09/13/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 10/22/2020; 11/18/2020
• Supplement Dates FDA Received: 10/26/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 64