BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2953185 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00943
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). CONCOMITANT PRODUCT: (B)(4), CRDM NON-DEFIB LEAD, (B)(6) 2004.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE LEAD INSULATION WAS BREACHED, OVERLAY TUBING WAS MELTED AND THERE WAS ENVIRONMENTAL STRESS CRACKING. THERE WAS OUTER INSULATION DEPRESSION. THE ANALYST'S VISUAL INSPECTION INCLUDED EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE DISCRIMINATORY CAPABILITY. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING AND A INAPPROPRIATE THERAPY WAS DELIVERED. THE LEAD WAS CUT/CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55407 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4) DEFIBRILLATOR