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

Model Number	37602
Medical Device Problem Codes	Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the caller indicated that the patient's wife thinks that the implanted device is going dead.When they checked the ins yesterday, the therapy was off and the wife turned therapy back on and that caused the patient to be jolted.The caller later described the sequence of events as the wife turned therapy on and then the patient woke up within a few minutes.The agent asked for clarification if the patient was jolted or if the patient just woke up and the caller stated that the patient's wife described the scenario both ways and could not clarify.The caller stated that the patient's wife never noticed that the therapy was turned off before and they didn't seem to know how stim was off.Troubleshooting was not required.The issue was not resolved through troubleshooting.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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
• 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: 14084113
• Report Number: 3004209178-2022-04586
• Device Sequence Number: 5251708
• Product Code: MHY
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• 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: 2018
• 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): 04/12/2022

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: 10/14/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/12/2022
• Date Device Manufactured: 04/23/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male