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

Model Number	5076-35
Medical Device Problem Codes	Pacing Problem (1439); Under-Sensing (1661)
Health Effect - Clinical Codes	Adhesion(s) (1695); Cardiac Arrest (1762); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Tachycardia (2095); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: addrl1 ipg doi: (b)(6) 2011 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 patient was found to be in ventricular fibrillation (vf) and cardiopulmonary resuscitation was administered by the emergency medical services.The patient was in pulseless electrical activity (pea) arrest and was hypertensive.Return of spontaneous circulation (rosc) was achieved.The patient was intubated and medicated.Undersensing and the inability to appropriately mode switch leading to inappropriately pacing that degraded into vt / ventricular fibrillation (vf).It was suspected that the scar mediated vt arrest.The patient had intermittent fever post admission and leucocytosis.A second-degree burn resulting from resuscitation caused a sternal wound resulting in an external hematoma.The ipg system remains in the patient and during the replacement procedure occlusion / adhesion were observed on the right ventricular (rv) lead and the right atrial (ra) lead.The ipg system was replaced on the right side of the patient.No further patient complications have been reported as a result of this event.
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.

• Brand Name: CAPSUREFIX NOVUS LEAD MRI SURESCAN
• 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: 20438332
• Report Number: 2649622-2024-27287
• Device Sequence Number: 12807913
• Product Code: DTB
• UDI-Device Identifier: 00681490729963
• UDI-Public: 00681490729963
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 08/31/2006
• Device Model Number: 5076-35
• Device Catalogue Number: 5076-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 09/08/2004
• 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: 5076-45 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 64 KG