BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 3241970 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12134
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    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 DEVICE WAS REPLACED BECAUSE OF THE SIZE OF THE DEVICE RELATIVE TO THE PATIENT¿S SMALL BODY. IT WAS ALSO NOTED THAT THE SKIN WAS SEVERELY STRETCHED OVER THE DEVICE CAUSING A POTENTIAL FOR PROTRUSION OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340405 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R IMPLANTABLE DEFIBRILLATION LEAD