BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2811900 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16885
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 2, 2013
    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
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY- THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE OVERLAY TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN APPARENT INSULATION BREACH. THE LEAD WAS CAPPED 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 83 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD