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

Model Number 8637-20

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

Patient Problems Erythema (1840); Pocket Erosion (2013); Rash (2033); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 09/28/2019

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 manufacturer representative on 2019-sep-30 regarding a patient receiving morphine (dose and concentration unknown) via an implanted infusion pump.The indication for use was spinal pain.It was reported that the patient had been experiencing a rash like symptom that per the hcp, looked more like an erythema.The patient was placed on topical steroid cream from their dermatologist, but ran out and couldn't get approval for more from their insurance.The patient was without the steroid cream for several weeks.Per the hcp, the patient reported what they described as blisters of new skin over the pump pocket.While shopping, the patient felt a releasing sensation and noticed their clothes and jacket were wet with fluid from the pocket.The patient left and went to the emergency room who bandaged the pocket site and sent the patient home.The patient presented to the emergency room again on (b)(6) 2019 and was again sent home.On (b)(6) 2019 the patient presented to the clinic and was admitted and brought into surgery where the pump and catheter were removed due to the pump eroding through the skin.The representative was unaware of any external factors that may have led or contributed to the issue or any troubleshooting performed related to the issue.Actions/interventions taken to resolve the issue included different topical creams given to the patient to try.The issue was considered resolved at the time of report and the patient's status was alive, no injury.No further complications were reported or anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9145805
• MDR Text Key: 166949313
• Report Number: 3004209178-2019-18828
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2019
• Date Device Manufactured: 07/13/2016
• 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: 57 YR