BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2811177 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05949
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 7, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE RIGHT VENTRICULAR (RV) COIL AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES WERE HIGH. DURING THE REVISION PROCEDURE IT WAS FOUND THAT THE RV COIL WAS NOT SECURELY TIGHTENED IN THE LEAD PORT. THIS CONNECTION WAS RE-TIGHTENED AND NORMAL IMPEDANCES WERE MEASURED AFTERWARD. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD