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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Event Date 03/09/2022

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 healthcare provider (hcp) via a company representative regarding a patient receiving dilaudid (1 mg/ml at.3002 mg/day) via an implanted pump.It was reported that the patient had an mri on (b)(6) 2022, but the pump logs showed the motor stalled 5 days later.The patient did not experience withdrawals and was still able to use their ptm (personal therapy manager).The patient did not recall any other magnets near the pump to cause a stall on (b)(6) 2022.Pump interrogation on (b)(6) 2022 at 12:02 pm indicated that the pump motor was stalled.Pump logs retrieved on (b)(6) 2022 at 12:13 pm indicated a pump motor stall message occurred on (b)(6) 2022 at 2:58 pm with a stopped pump duration exceeded 48 hours message on (b)(6) 2022 at 2:58 pm and the pump motor stall recovery message on (b)(6) 2022 at 12:06 pm.No surgical intervention occurred, and none was planned.The plan was to monitor the pump.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: 13768969
• MDR Text Key: 289343743
• Report Number: 3004209178-2022-03275
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Physician
• Report Date: 03/15/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial