MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number B35200

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Distress (2329); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a change made to the patients programming and since then, every time she tries to make a change with the stimulation she gets shocked where one of the leads is located in her head.The rep asked when this started to happen but the patient was in such distress that she was challenging to understand and the rep could not understand the patient's answer.The rep had linked the previous and current implants as the caller was not clear on if this issue of the shocking sensation was isolated to only the current ins or if this issue started on the previous ins and continued with the new ins.The patient was redirected to follow up with her hcp and the patient stated that she was trying to get an appointment with her surgeon hcp as the physicians assistants were not willing to do anymore programming and thought that the ins needed to be replaced.The rep offered to reach out to the medt ronic field rep on the patients behalf as her ins has not been checked and she is needing assistance.No further complications was reported.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11638275
• MDR Text Key: 266426427
• Report Number: 3004209178-2021-05737
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• 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: 04/08/2021

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: 07/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/08/2021
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1