MAUDE Adverse Event Report: MPRI CAPSUREFIX LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5568-53
Medical Device Problem Codes	Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited undersensing at times and far field r-wave (ffrw) oversensing resulting in inappropriate mode switching.It was also reported that there were possible high left ventricular (lv) lead thresholds and high right ventricular (rv) lead thresholds noted.Additionally, the cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy for ventricular tachycardia (vt) with 1:1 retrograde detected as supra ventricular tachycardia (svt) via the device feature that uses pattern and rate analysis to discriminate between svt and true ventricular tachyarrhythmias.It was also previously observed that the crt-d inappropriately withheld therapy for vt detected as svt via the device feature designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of an svt origin.The ra, rv and lv leads and device remain in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtpa2q1 crt-d implanted: (b)(6) 2024.429888 lead implanted: (b)(6) 2014 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
It was reported that the right atrial (ra) lead exhibited undersensing at times and far field r-wave (ffrw) oversensing resulting in inappropriate mode switching.It was also reported that there were possible high left ventricular (lv) lead thresholds and high right ventricular (rv) lead thresholds noted.Additionally, the cardiac resynchronization therapy defibrillator (crt-d) inappropriately withheld therapy for ventricular tachycardia (vt) with 1:1 retrograde detected as supra ventricular tachycardia (svt) via the device feature that uses pattern and rate analysis to discriminate between svt and true ventricular tachyarrhythmias.It was also previously observed that the crt-d inappropriately withheld therapy for vt detected as svt via the device feature designed to withhold inappropriate ventricular detection if the rhythm displays characteristics of an svt origin.The ra, rv and lv leads and device remain in use.No further patient complications have been reported as a result of this event.It was further reported that the patient was seen in clinic and the lv lead and rv lead thresholds were within normal limits.The ra lead and crt-d were reprogrammed.

• Brand Name: CAPSUREFIX LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 21859026
• Report Number: 2649622-2025-10477
• Device Sequence Number: 7982009
• Product Code: DTB
• UDI-Device Identifier: 00885074248592
• UDI-Public: 00885074248592
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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
• Report Date (Section B): 05/01/2025

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: 11/19/2009
• Device Model Number: 5568-53
• Device Catalogue Number: 5568-53
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/01/2025
• Date Device Manufactured: 11/28/2007
• 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: 694765 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 103 KG