BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS DR

    MDR report key: 1861684 · Received October 8, 2010

    Report

    Report Number
    2647346-2010-00589
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S23
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): ANALYSIS REVEALED NORMAL BATTERY DEPLETION AND THE DEVICE MEETS 80% OF EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE DEVICE PATIENT ALERT SOUNDS EVERY DAY FOR THE PAST TWO YEARS. PATIENT REPORTED THAT DURING IN CLINIC FOLLOW UP CHECKS, THE NURSE DOES NOT SEE ANYTHING. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS ALSO REPORTED BY THE CLINICIAN THAT THE ALARM WAS SOUNDING BECAUSE THE DEVICE HAD BEEN REPROGRAMMED TO VVI AND THE ATRIAL ALARM WAS NOT TURNED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE DEVICE PATIENT ALERT SOUNDS EVERY DAY FOR THE PAST TWO YEARS. PATIENT REPORTED THAT DURING IN CLINIC FOLLOW UP CHECKS THE NURSE DOES NOT SEE ANYTHING. DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7274 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD