BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2811068 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16580
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    January 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR WAS FRACTURED. THE DEFIBRILLATOR SVC WAS KINKED/BUCKLED. THE DEFIBRILLATOR SVC WAS FRACTURED. THE DISTAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED), THE DISTAL END ELECTRODE WAS PULLED/STRETCHED/OVERSTRESSED. THE DISTAL END ELECTRODE WAS COVERED IN BLOOD. THE HELIX WAS BENT. THE INSULATION OVERLAY TUBING WAS CUT, MELTED AND HAD ENVIRONMENTAL STRESS CRACKING. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THE INNER INSULATION WAS PULLED. STRETCHED AND OVERSTRESSED. THE OVERLAY TUBING WAS KINKED/BUCKLED. THERE WAS AN OBSERVATION OF BLOOD INGRESSION ON THE OVERLAY TUBING. IT WAS VISUALLY NOTED THAT THE LEAD WAS STRETCHED.

    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 THERE WAS UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. 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 FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB