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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Sleep Dysfunction (2517); Insufficient Information (4580)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On b)(6) 2021, information was received from a patient receiving dilaudid (unknown dose and concentration) via an implantable pump for spinal pain. It was reported the patient had been going though withdrawals for 4-5 days. On the patient's 8835 ptm, they were getting code 8532 (stopped pump may exceed tube set). The patient stated they have gone to the emergency room two times due to withdrawals. The patient stated they could not function, their skin was crawling, could not sleep and could not "do anything". The patient thought they were having an anxiety attack and they even changed the patient's anxiety mediations. The patient's last refill was (b)(6) 2021. The patient has not had any mris recently. The patient stated they called their hcp and they have him coming in next week, thursday, to replace the pump. The patient then stated the pump alarmed about 4-5 days ago and has not alarmed for the last 1. 5 - 2 days that they could recall. End of service was reviewed with the patient. The patient stated their hcp told them they were still getting dilaudid even though the pump was not functioning. Troubleshooting was not required. The issue was not resolved as troubleshooting was not needed. The patient was redirected to their hcp to further address the issue.

• 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: 13022478
• MDR Text Key: 287927508
• Report Number: 3004209178-2021-18690
• Device Sequence Number: 1
• Product Code: LKK
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/16/2021 Patient Sequence Number: 1