BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST VR

    MDR report key: 1922125 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05862
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    July 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT WAS SHOCKED 4 TIMES IN 3 DAYS BY THE DEVICE, A SINGLE-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). ACCORDING TO THE MANUFACTURER'S IMPLANT DATABASE, THE DEVICE WAS REPLACED WITH A DUAL-CHAMBER ICD. THE PATIENT SAID THERE HAD SEEMED TO BE SOME CONCERN WITH THE FIRST DEVICE. THE PATIENT WANTED TO KNOW IF THERE WAS SOMETHING WRONG WITH THE DEVICE OR THE PROGRAMMING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 6932 IMPLANTABLE TACHY LEAD