BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO LEAD

    MDR report key: 1924326 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13516
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    October 21, 2022
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUPERIOR VENA CAVA COIL DEFIBRILLATION LEAD WAS SHOWING A WIDE VARIANCE IN IMPEDANCE. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other 5554 IMPLANTABLE PACING LEAD| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| DDMB1D1 ICD| 5554 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB