BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA CRT-D

    MDR report key: 2791178 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05723
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 14, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO IMPLANT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE DEVICE WAS ATTEMPTED BUT NOT USED. THE SYSTEM WAS IMPLANTED FROM THE RIGHT SIDE AND WHEN THE DEVICE WAS CONNECTED IT WAS UNABLE TO DEFIBRILLATE THE PATIENT. THE DECISION WAS MADE TO IMPLANT ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD