BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2810858 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06162
    Event Type
    Injury
    Date Received
    October 31, 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 THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT PROCEDURE DUE TO HIGH PACE/SENSE IMPEDANCE AND NON-CAPTURE FOLLOWING A DEVICE CHANGEOUT A FEW MONTHS AGO. DURING THE PROCEDURE, THE DEVICE WAS OBSERVED UNDER FLUOROSCOPY. IT WAS NOTED THAT THE PACE/SENSE PIN WAS NOT FULLY SEATED IN THE DEVICE HEADER. AFTER OPENING THE POCKET AND REMOVING THE DEVICE, THE PHYSICIAN WAS ABLE TO EASILY PULL THE LEAD FROM THE HEADER. THE PHYSICIAN THEN NOTICED THAT THE PROXIMAL END OF THE INSULATION ON THE RIGHT VENTRICULAR LEAD WAS "BUNCHED UP". HE CONCLUDED THAT THIS WAS THE REASON THAT THE LEAD WAS NOT ABLE TO BE FULLY ADVANCED IN THE DEVICE HEADER. THE PHYSICIAN DECIDED TO PLACE A NEW PACE/SENSE LEAD AND CAP THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR LEAD. NO PATIENT COMPLICATIONS WERE 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 83 YR Hospitalization| R 0184 COMPETITOR IMPLANTABLE TACHY LEAD| 4472 COMPETITOR IMPLANTABLE PACING LEAD