BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152159 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00516
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS OUT OF SPECIFICATION, THE BATTERY CONTACTS WERE COMPRESSED AND THE RING BAIL WAS BENT.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB DUE TO BATTERY REMOVAL TEST FAILURE. THIS ANALYSIS CONFIRMED THE CAUSE TO BE A CAPACITOR COMPONENT FAILURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BATTERY OF THE EXTERNAL PULSE GENERATOR (EPG) WAS BEING REMOVED WHILE CONNECTED TO A PATIENT, WHEN THE EPG IMMEDIATELY SHUT OFF. THE EPG SHUT OFF BEFORE THE FIFTEEN SECONDS WAS UP, WHEN THE BATTERY WAS REMOVED. THE PATIENT WENT ASYSTOLE, BUT RECOVERED WITH ANOTHER DEVICE. THE EPG WAS RETURNED FOR REPAIR. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252930 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R