BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4161244 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02726
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED DEVICE SHUT DOWN; DEVICE PASSED ALL INCOMING FUNCTIONAL TESTS AND BENCH TESTING. DEVICE RAN IN ENVIRONMENTAL CHAMBER AND AFTER 48 HOURS NO ANOMALIES WERE OBSERVED. ANALYSIS FOUND THE LEAD FLEX O-RING WAS STRETCHED OUT. BATTERY RETURNED WITH DEVICE MEASURED 8.69 VOLTS NO LOAD AND UNDER 128 OHM LOAD BATTERY MEASURED 8.36 VOLTS. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHUTDOWN WHILE HOOKED TO AN ASYSTOLE PATIENT. UNIT PACING LIGHTS REMAINED ON BUT SCREEN WENT BLANK WITH NO OUTPUT TO THE PATIENT. THE CALLER DISCONTINUED USE IMMEDIATELY. CALLER BELIEVES BATTERY IN UNIT NOW IS SAME BATTERY AS WHEN INCIDENT HAPPENED. THE CALLER MEASURED THE VOLTAGE AT 8.65 V. THE NEW BATTERY MEASURED 9.71 V. THE DEVICE HELD CHARGE FOR 36 SECONDS AFTER BATTERY WAS REMOVED FROM DEVICE. CLINIC HAS INVESTIGATION OPEN AND NEEDS FURTHER EVALUATION OF DEVICE. THE EXTERNAL PULSE GENERATOR (EPG) HAS BEEN RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638860 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R