BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3160336 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-08020
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) - 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY MEMBER CALLED TO REPORT THAT THE PATIENT WAS SENT TO THE HOSPITAL BECAUSE THEIR LEAD FAILED AND STARTED SHOCKING THE PATIENT. THE LEAD WAS DISCONNECTED AND A COMPETITOR'S PACING LEAD, WHICH HAD BEEN PREVIOUSLY INACTIVATED, WAS CONNECTED TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259758 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R