MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37601
Medical Device Problem Codes	Failure to Deliver Energy (1211); Battery Problem (2885)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's ins was turning off.The patient was seen in (b)(6) 2021 and ins voltage was 2.71v.This last weekend the pt wife reached out to caller due to ins turned off.When checking w/ patient programmer the voltage was 2.6 and read eri, and was able to turn stim back on.No intervention with patient programmer when ins turned off.Today ((b)(6) jun 2021) the patient started to have tremors, the ins was checked w/ patient programmer and indicated the ins turned off again.The wife turned ins back on and noted 2.2v and eri on the patient programmer.The caller indicated the ins has been on for the past 3 hours.They were directed to their physician to discuss replacement.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12074826
• Report Number: 3004209178-2021-10027
• Device Sequence Number: 4411644
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR