BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152847 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00581
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE BATTERY VOLTAGE WAS LOW, AT 6.1 VOLTS. LOW BATTERY INDICATION IS 7.2 VOLTS NOMINAL AND END OF OPERATION IS AT 6.3 VOLTS NOMINAL. IT WAS ALSO NOTED THAT THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, THE CONTROL KNOBS WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED AND THE RING WAS BENT.

    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 EPG (EXTERNAL PULSE GENERATOR) SHUT OFF ON ITS OWN DURING A PREVENTIVE MAINTENANCE CHECK. IT WAS FURTHER NOTED THE EPG WOULD ALSO SHUT OFF WHEN THE BOTTOM CASE WAS SQUEEZED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257837 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1