BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2955396 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02095
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 6, 2012
    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
    AR, 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. CONCOMITANT PRODUCT: 0292 COMPETITOR DEFIBRILLATION LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SINCE THE DATE OF IMPLANT, THEY HAVE FELT THE DEVICE "MOVING INSIDE". AT A DEVICE CHECK IT WAS REPORTED THAT THE DEVICE WAS "FLIPPED AND LEADS ARE OUT OF PLACE". THE PATIENT IS SCHEDULED FOR SURGERY TO CORRECT THE DEVICE AND LEADS. THE DEVICE AND LEADS ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58822 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD