MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37602
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received two "major shocks" from their dbs implant during a nerve conduction study in 2020.They do not remember if they turned both of the implants off before the study.Patient discontinued the study after the second shocking incident.The issue resolved.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received from the manufacturer¿s representative (rep) reported the cause of the shocking wasn¿t determined.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19746735
• Report Number: 2182207-2024-03132
• Device Sequence Number: 21045388
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 12/28/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/24/2024
• Date Device Manufactured: 06/30/2015
• 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: 52 YR
• Patient Sex: Male