BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRINSIC

    MDR report key: 2203434 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-04181
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND FOUND TO HAVE NORMAL DEPLETION AND MET 80% OF EXPECTED LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT "TAPPING" SENSATION IN THE HEART. THE SENSATION WAS PRESENT FOR FOUR DAYS AND LASTED UP TO 1.5 HOURS. A SIMILAR PATTERN OCCURRED THREE TIMES LAST YEAR PRIOR TO SYNCOPAL EPISODES AND HOSPITALIZATION. ITERATIVE TESTING REVEALED NORMAL DEVICE AND LEAD FUNCTION. THE PATIENT NOTED THE "TAPPING" SENSATION WITH THRESHOLD TESTING. THE PATIENT DEVELOPED AN INCREASED HEART RATE. THE PATIENT ALERT TONE WAS TRIGGERED ON THE DEVICE FOR ELECTIVE REPLACEMENT INDICATOR (ERI) AND EXCESSIVE CHARGE TIME WERE TURNED OFF. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD