BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT DR

    MDR report key: 3002062 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03638
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    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. CONCOMITANT PRODUCT: 6947 IMPLANTABLE DEFIBRILLATION LEAD (B)(6) 2013. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    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 CODED AND DIED AFTER THE IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO VENTRICULAR FIBRILLATION ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104662 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death 5076 IMPLANTABLE PACING LEAD