BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1862802 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10544
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 23, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS REVEALED THAT THE LEAD WAS FRACTURED. IT WAS ALSO NOTED THAT THE LEAD WAS PULLED/STRETCHED/OVERSTRESSED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH THRESHOLD WHICH INCREASED THE RISK OF FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH THRESHOLD WHICH INCREASED THE RISK OF FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention 7230 IMPLANTABLE PACEMAKER/CARDIO/DEFIB