MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

Model Number	407645
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/01/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient went into cardiac arrest after multiple ventricular fibrillation (vf) episodes.A device interrogation indicated right atrial (ra) lead undersensing.Right ventricular (rv) lead undersensing was also noted, possibly due to morphology.A lead integrity alert (lia) triggered on the rv lead due to high rate non-sustained episodes and short ventricular intervals.The patient's family opted with withdraw care and the patient expired.Additional information was requested but not obtained.
Additional Manufacturer Narrative
Continuation of d10: dtma1qq crt-d, implanted on (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.

• Brand Name: CAPSUREFIX NOVUS MRI SURESCAN
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20494155
• Report Number: 3008973940-2024-07740
• Device Sequence Number: 3554169
• Product Code: DTB
• UDI-Device Identifier: 00763000014636
• UDI-Public: 00763000014636
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 11/07/2019
• Device Model Number: 407645
• Device Catalogue Number: 407645
• 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: 10/01/2024
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 11/22/2017
• 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: 6935M55 LEAD, 459888 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 105 KG