BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2813164 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06468
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 9, 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
    OH, 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 THREE MONTHS AFTER THE DEVICE IMPLANT PROCEDURE, THE PATIENT PRESENTED WITH DETECTIONS OFF. IMPLANT DETECTION WAS NOT ACTIVATED AT THE IMPLANT PROCEDURE. THE DEVICE WAS REPROGRAMMED AND REMAINS 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 XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD