MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Improper Flow or Infusion (2954)

Patient Problems Pain (1994); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving morphine (40 mg/ml at 8 mg/day) via an implantable pump. It was reported that the patient's pump was refilled on (b)(6) 2022 and the following day, the patient was in intensive care unit because of overdose symptoms. Factors that may have led or contributed to the issue was noted as being not applicable. The healthcare provider who performed the refill was sure they didn't refill the pump pocket. The pump was first put in a minimal rate. The patient was reactive. The pump was emptied on (b)(6) 2022 and there was 10 ml removed instead of approximately 10 ml. The healthcare provider decided to shut down the pump (definitive) and to deal with the patient symptoms with other treatments. The healthcare provider was informed that the pump would not be able to work again and that the overdose / withdrawal symptoms had to be taken in charge. The issue was not resolved as of (b)(6) 2022. The pump remained implanted and out of service. No surgical intervention occurred and it was unknown if surgical intervention was planned. The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13537258
• MDR Text Key: 288381493
• Report Number: 2182207-2022-00261
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 05/13/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 02/15/2022 Patient Sequence Number: 1