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

Model Number	37601
Medical Device Problem Codes	Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Data Problem (3196)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that about 6 months ago the patient's therapy settings "all the sudden went to 10 by itself" and the patient felt shocks in their head.The patient also mentioned that they were seeing the eri screen on their patient programmer.The patient's relevant medical history included that they have essential tremor that they state  kind of progressed to early stage parkinson's.
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 consumer reported they were sure the ins was running out of battery, and they asked how to check the ins battery status.The patient programmer indicated that therapy was off and the ins battery was at eri with voltage of 2.58.The patient stated that they already notified their hcp that their ins had reached eri, but their surgeon told the patient that due to "other medical reasons" they could not replace the ins until december or january.The patient was concerned that the ins would reach eos before that time.The patient mentioned that they cannot function when therapy is turned off, noting that they can't eat or shower because their tremors are extreme.The patient mentioned that they already turn therapy off before they go to sleep, and they asked what else they could do to extend the ins battery life.The patient was advised to discuss this with their hcp.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 19615868
• Report Number: 3004209178-2024-13607
• Device Sequence Number: 20337975
• Product Code: PJS
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 05/28/2018
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/26/2024
• Date Device Manufactured: 12/03/2016
• 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 Sex: Male