BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRINSIC

    MDR report key: 2790456 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05599
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. THE BATTERY VOLTAGE WAS NOTED TO BE PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT EQUAL TO 2.88 TO 2.68 VOLTS BETWEEN 09-JAN-2012 AND 20-AUG-2012, WHICH IS BEFORE DEVICE ERI LESS THAN OR EQUAL TO 2.62 VOLTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY LONGEVITY WAS LESS THAN EXPECTED. DEVICE PERFORMANCE DATA WAS ANALYZED; IT WAS NOTED THAT THE BATTERY TREND SHOWED A HIGHER CURRENT DRAIN FOR A LONG TIME, AND THIS WAS NOT CONSISTENT WITH THE USAGE OR SETTINGS. THE DEVICE 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 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD