BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2953449 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00331
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED POSSIBLY MORE THAN NINE TIMES. THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TURNED OFF. FOLLOW UP INFORMATION INDICATED THAT THE SHOCKS WERE INAPPROPRIATE AND WERE DUE TO A LOOSE LEAD. THE LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57838 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 694865

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Life Threatening| R D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR