BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT DR

    MDR report key: 2791585 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05733
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 12, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR [RV] LEAD HAD NORMAL MEASUREMENTS WHEN CONNECTED TO THE ANALYZER, BUT WHEN THE RV LEAD WAS CONNECTED TO THE DEVICE, T-WAVE OVERSENSING [TWOS] WAS NOTED. TWOS WERE NO LONGER PRESENT WHEN THE SENSITIVITY WAS DECREASED; HOWEVER, THE PHYSICIAN OPTED TO IMPLANT A DIFFERENT DEVICE. 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. D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other 4469 COMPETITOR IMPLANTABLE PACING LEAD| 0295 COMPETITOR IMPLANTABLE TACHY LEAD