MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	37603
Medical Device Problem Codes	Break (1069); High impedance (1291); Battery Problem (2885); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the battery was at 2.59v, and the eri alert did not appear.Patient is being referred for replacement.On 2026-feb-10 fu_mpxr 1388681 (hcp, rep): additional information was provided by the manufacturer representative on february 10th indicating high impedance at contact 3 on both hemispheres: on the left gpi, contact 3 monopolar measured 2293 ohms; on the right gpi, all configurations involving contact 3 (monopolar and bipolar) were out of range; neither of these contacts is currently used in the patient¿s programming configuration.
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 the battery was at 2.59v, and the eri alert did not appear.Patient is being referred for replacement.Additional information was provided by the manufacturer representative, indicating high impedance at contact 3 on both hemispheres: on the left gpi, contact 3 monopolar measured 2293 ohms; on the right gpi, all configurations involving contact 3 (monopolar and bipolar) were out of range; neither of these contacts is currently used in the patient¿s programming configuration.The manufacturer representative provided additional information indicating that, per the clinician, the implantable neurostimulator reached the eri status due to normal battery depletion.
Event or Problem Description
Full narrative provided by rep: patient had bilateral battery replacement and bilateral extension revision done (b)(6) 2026.It was ob served that the patient had metal dog bones over the extension lead connection points.Additionally, there were no sutures over the legacy boots.This was done outside the us.The clinician felt this could likely have contributed to the impedance issue, since when he removed the metal dog bones both extensions were kinked/dented from the metal.Left lead and extension observations: when the left lead was disconnected from the old extension there were only 3 intact contacts.There was not a fourth contact and when the surgeon inspected the extension there was no 4th contact in the barrel of the old extension.When the left lead was connected to the new extension the surgeon lined up the lead and extension contacts as before.The outcome was with in normal limits impedance for contact 0,1,2 and out of range impedance(>5k) on contact 3 and all bipolar combos with contact 3.Stim was able to be programmed consistent with pre-op setting and no oor alerts were received.Right lead and extension observations; this was also tied down with a metal dog bone.The surgeon removed this.No tie was observed on the legacy boot and it was also observed that the set screws were not torqued down.The surgeon felt this may have contributed to the out of range impedance.The extensions was replaced and when the lead and extension was connected to the new battery impedance was all with in normal limits and stim was able to be programmed to pre op settings.The last piece of info collected was data from left chest battery (b)(6) 2026 it did appear when device was interrogated but this must have happened between the last clinician interrogation and this battery replacement.
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_ext lot# serial# unknown implanted: (b)(6) 2015 explanted: (b)(6) 2026 product type extension product id 37603 lot# serial# (b)(6) implanted: (b)(6) 2023 explanted: (b)(6) 2026 product type implantable neurostimulator product id neu_unknown_ext lot# serial# unknown implanted: (b)(6) 2015 explanted: (b)(6) 2026 product type extension.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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 24423696
• Report Number: 3004209178-2026-03064
• Device Sequence Number: 5939966
• Product Code: MRU
• UDI-Device Identifier: 00763000519230
• UDI-Public: (01)00763000519230(17)240414
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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: 04/14/2024
• Device Model Number: 37603
• Device Catalogue Number: 37603
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 03/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/12/2026
• Date Device Manufactured: 10/19/2022
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female