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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen with concentration 2000 mcg/ml at a dose rate of 376,1 mcg/day (flex dose rate) via an implantable pump. It was reported that the patient was hearing three times beeping of her pump every ten minutes. On (b)(6) 2020 another specialized nurse visited the patient for checkup and to read the pump logs. As per the logs a critical alarm regarding motor stall occurred on (b)(6) 2022 at 18:36 followed by a motor stall recovery on (b)(6) 2022 at 19:06. Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient drove in a taxi van with no iphone, and with the belt positioned on the wheelchair (not on their belly). During phone call, and after another an hour of contact, nothing more was to be heard. The patient did not experience any complaints; therefore, no further actions were taken. No catheter issue was observed. No surgical intervention occurred and no surgical intervention was planned. The issue was resolved as of (b)(6) 2022. The patient was without injury regarding their status as of (b)(6) 2022. The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, lot#: unknown, product type: catheter. The date (b)(6) 2022 is considered an approximate date of implant (specific month and year known only). If information is provided in the future, a supplemental report will be issued.

• 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: 14215064
• MDR Text Key: 290575280
• Report Number: 3004209178-2022-05278
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial