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

Model Number	37603
Medical Device Problem Codes	Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Electric Shock (2554); Insufficient Information (4580)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.Continuation of d10: product id 37603 (b)(6); product type: 0197-implantable neurostimulator; implant date (b)(6) 2022 ; 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that maybe 6 months ago, the patient was being electrocuted.The caller stated they were clairvoyant and that they had heard a voice telling them to go to the patient and that they rang to the patient's house and found the patient on the couch screaming, their face blue and gray. the caller stated the patient was being electrocuted.The caller stated the patient's husband had walked in and the caller tried to reboot the controller but the patient continued to be electrocuted so the caller turned the therapy off, which they stated was hard to do because they were unfamiliar with the system and the patient had two sides.Caller stated patient's coloring returned to normal after they turned the therapy off.Caller stated the patient then went to their managing health care provider and the healthcare provider told the patient "if your friend hadn't of come, you would have been dead" and then turned the stimulation back on.Caller stated they were dismayed the hcp turned the therapy back on because they thought there was something wrong with the wires so the caller told the patient to turn the therapy off.Caller stated the patient turned the therapy off.Patient services offered to transfer the caller to dbs to discuss this event but the caller declined and stated "i think the patient should be the one to tell it".Patient services redirected the caller to have the patient follow up with the hcp to get medical guidance for their situation and that the hcp was the medical professional and caller stated "well since it's been off, she hasn't had a facial tremor since." caller stated the patient had the ins for facial tremors.
Event or Problem Description
Additional information received from the healthcare provider (hcp) reported the event occurred at home.The device was briefly turned on during the clinic visit after the event without any issues of shocking or other adverse effect.The cause wasn¿t determined.The device remained off without stimulation per the patient¿s request.
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
It was reported that all 4 contacts had high impedances and the patient has had no falls or trauma.The monopolar contacts impedance values were as follows: contact 0- 7913, contact 1- 5394, contact 2- 4746, and contact 3- 5394.The bipolar contacts impedance values were as follows: contact 0-3 7148, contact 0-2 5495, contact 0-1 7923, contact 3-2 2327, 0-2 5495, 0-3 7148, 2-1 2602, 1-0 3747, and 1-3 3942.The implantable neurostimulators (ins) have been turned off for now.The issue has not been resolved at the time of this report.No symptoms were reported.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the cause of the high impedances wasn¿t determined.Nothing was done at this time and the issue hadn¿t been 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.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19679928
• Report Number: 3004209178-2024-14187
• Device Sequence Number: 19643111
• Product Code: MHY
• UDI-Device Identifier: 00763000384340
• UDI-Public: 00763000384340
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024

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: 03/14/2023
• Device Model Number: 37603
• Device Catalogue Number: 37603
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 09/10/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/10/2024
• Date Device Manufactured: 09/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female