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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Weight Changes (2607); Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

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 an unknown medication via an implanted pump.The indication for pump use was non-malignant pain.The patient reported that since the pump was implanted, she had relief of all her symptoms which was not normal for her illness, but she was thankful for the relief.Since november, she had been suffering and not getting any pain relief.She stated that she would occasionally have a day of relief, but every 2-4 days had no relief.The pain was so severe that she lied in bed all day and couldn¿t eat so had lost eight pounds.Her hcp (healthcare provider) had been great and had performed a dye study.The patient was asking if the battery could go bad.She confirmed she had heard no alarms and was able to bolus as desired.Her hcp had increased the pump which did not resolve her symptoms.When asked if she had any falls/trauma she stated no but in 2019 when her dad died, she fell on the pump and now the tip was sticking out and she could feel it and it was sore to the touch.She stated that she didn¿t over-exert herself stating that she didn¿t vacuum or bend down.She stated that the pump was heavy and sometimes it hurt due to being heavy.The patient was redirected to her hcp for her medical concerns.She stated that she had an appointment thursday and her doctor had been great and she didn¿t want them to think she was not grateful.

• 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: 13838542
• MDR Text Key: 287547259
• Report Number: 3004209178-2022-03514
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2022

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: 01/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/21/2022
• Date Device Manufactured: 08/05/2019
• 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 Age: 50 YR
• Patient Sex: Female