BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1891575 · Received November 5, 2010

    Report

    Report Number
    2649622-2010-12032
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    August 13, 2010
    Report Date
    February 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - NO ANOMALIES FOUND. TRENDS APPEAR STABLE. OVERSENSING - MULTIPLE SHORT V-V SENSED EVENTS OF < 220 MS ARE OBSERVED ON THE (B)(6) 2010. (11 EPISODES NST, 2 EPISODES VF).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND HAD SIGNIFICANT HISTORY OF BOTH ATRIAL AND VENTRICULAR ARRHYTHMIAS BASED ON EPISODE COUNTERS. PRIOR TO DEATH, THERE WERE 3 VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION EPISODES THAT APPEAR TO HAVE BEEN DETECTED AND TREATED APPROPRIATELY. "POST SHOCK THERE APPEARED TO BE TRANSIENT LOSS OF CAPTURE." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Death 4196 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD