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 Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Seroma (2069); Burning Sensation (2146); Sleep Dysfunction (2517)

Event Date 07/01/2020

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 consumer regarding a patient receiving hydromorphone via an implanted pump.The indication for pump use was non-malignant pain.The patient reported that shortly after the pump was implanted, the wound opened up and you could see the pump through her stomach.The hcp told her it seemed fine and closed the wound, but it had an infection later on and he had to go back in to clean it out.One time after that, she had fluid drained off.About a month ago, she started having really bad pain where the pump was.She stated that the majority of days it ¿feels like i¿m being stabbed¿; ¿like a burning or tearing sensation from the pump site¿ if she got up from sitting and/or laying.Her hcp gave her a lidoderm patch to put over the pump, but it didn¿t help much.She stated that her hcp wasn¿t being very helpful and wasn¿t able to see her for another week.She stated that she wasn¿t sleeping because when she turned over it felt like she was ¿being gutted¿.She was calling because she wanted to know if other people had issues like this.The patient was encouraged to work with her hcp after which she stated that she was getting frustrated because she felt like she was not being taken care of as far as this issue was concerned.When asked about the medication in the pump, the patient stated that the pain had never been totally controlled with the pump.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12092392
• MDR Text Key: 259154833
• Report Number: 3004209178-2021-10170
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Date Device Manufactured: 04/21/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR