BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2953020 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01877
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    July 19, 2012
    Report Date
    November 21, 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
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE TRIGGERED A LEAD INTEGRITY ALERT. A FRACTURE WAS SUSPECTED. DURING THE REVISION PROCEDURE, NOISE WAS INITIALLY NOTED AND THE PHYSICIAN WAS ABLE TO TIGHTEN THE SETSCREW. THE LEAD WAS DISCONNECTED, TESTED WITH THE ANALYZER, AND WAS DETERMINED TO BE FINE. THE PHYSICIAN FELT THAT THE LEAD HAD NOT BEEN FULLY INSERTED NOR TIGHTENED DURING THE INITIAL IMPLANT. THE LEAD AND THE DEVICE REMAIN 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
    56680 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314VRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 6947M IMPLANTABLE TACHY LEAD