MAUDE Adverse Event Report: Medtronic Neuromodulation CAPSURE EPICARDIAL LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number	4965-35
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: 4968-35 lead (x2) implanted (b)(6) 2011; dtma1d1 crt-d implanted (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.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 by the clinician that there was a large current drain on the device and that the longevity was estimated at three years on a recently implanted device.It was further reported there was far field r wave oversensing.Additional information obtained indicated the longevity estimated was due to a need to "recalibrate" the device and the estimate provided by technical services was what was expected, approximately nine years.Multiple attempts to program around the oversensing were unsuccessful.It was reported approximately thirteen years later that the far field r-wave (ffrw) oversensing continued resulting in inappropriate mode switching and accounting of atrial fibrillation (af) burden.Double counting of r-waves was also noted and associated with latent left ventricular paces being sensed on the right ventricular channel.The right atrial (ra) and right ventricular (rv) leads and the device remain in use.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the right ventricular (rv) lead triggered a lead integrity alert (lia) due to high rate non-sustained episodes and short ventricular intervals.The rv lead was exhibiting crosstalk, described as oversensing that appeared to happen with atrial pacing, and was associated with pacing inhibition.It was also reported that the right atrial (ra) lead exhibited noise, and atrial noise was picked up on the rv lead.The patient was programmed to ventricle-only pacing and sensing.It was stated that the patient feels normal without atrioventricular (av) synchrony but not without ventricular synchrony.The leads were explanted.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: d4.Unique identifier (udi)#.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: CAPSURE EPICARDIAL LEAD
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• Manufacturer (Section D): Medtronic Neuromodulation; 7000 central ave ne; minneapolis 55432
• Manufacturer (Section G): Medtronic Neuromodulation; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; 7635269277
• MDR Report Key: 22113962
• Report Number: 2182208-2025-02639
• Device Sequence Number: 4122801
• Product Code: NVN
• UDI-Device Identifier: 00681490116503
• UDI-Public: (01)00681490116503(17)990928
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: Lay User/Patient
• Device Expiration Date: 09/28/1999
• Device Model Number: 4965-35
• Device Catalogue Number: 4965-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 09/29/2026; 09/02/2026
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 09/29/2026; 09/30/2026
• 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: 6996SQ58 LEAD (X2), 6996SQ41 LEAD, 672625 ADAPTOR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male