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

Model Number	37603
Medical Device Problem Codes	Malposition of Device (2616); Battery Problem (2885)
Health Effect - Clinical Codes	Discomfort (2330); Shaking/Tremors (2515)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that for 3 months they have noticed uncontrolled tremor on their right side and have been increasing amplitude because of that.They have been monitoring the implantable neurostimulator (ins) battery voltage which dropped from 2.6 to 2.59 over the span of 3-4 days which patient was concerned was really fast, and patient wondered why it had not triggered eri yet.Reviewed eri occurs at 2.58v.Patient reported they had battery replacement originally scheduled for tomorrow but their surgeon cancelled and rescheduled it for 8 weeks away.Patient additionally reported that they do not like how high up their right side battery was placed and it has bothered them since implant.Patient also stated that their surgeon thought patient may have pulled the wires out of the battery.Recommended patient discuss these concerns with their physician.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.Continuation of d10: product id 37603 ((b)(6)); product type: 0197-implantable neurostimulator; implant date (b)(6) 2020; 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 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: 24506662
• Report Number: 3004209178-2026-03994
• Device Sequence Number: 13376069
• Product Code: PJS
• UDI-Device Identifier: 00763000100353
• UDI-Public: (01)00763000100353(17)210928
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 09/28/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 04/01/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female