BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152945 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00584
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. MAIN PRINTED CIRCUIT BOARD (PCB) ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE UPPER CASE, LOWER CASE, AND SIDE BAIL COVERS ARE BROKEN. THE LEAD FLEX COVER FOUND CORRODED. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS FOUND THAT A CAPACITOR COMPONENT FAILURE CAUSED THE DEVICE BATTERY REMOVAL TEST 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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) IMMEDIATELY SHUTS OFF WHEN BATTERY DRAWER IS OPENED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254869 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1