BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA DR

    MDR report key: 2791262 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05632
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 30, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S218
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PACE/SENSE IMPEDANCES ON THE RECENTLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD WERE VARYING/HIGH. THE LEAD WAS RESET IN THE HEADER OF THE DEVICE, WHICH SOLVED THE PROBLEM. THE LEAD AND 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
    1 PROTECTA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D334DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD