BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153027 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00570
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT WITH A TEST BATTERY THAT HAD THE DIMENSIONS OF THE REPORTED EVENT 44 MILLIMETERS (MM), NOT THE BATTERY THAT WAS RETURNED WITH THE DEVICE. THE DEVICE FUNCTIONED NORMALLY WITH A STANDARD 9-VOLT ALKALINE RECOMMENDED BATTERY. THE CUSTOMER USED A 9-VOLT BATTERY OF HEIGHT = 44.2 MM. THIS MODEL IS NOT SPECIFIED FOR A BATTERY OF 44.2 MM HEIGHT.

    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 THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD TURN ITSELF OFF. THE EPG HAD INTERMITTENT SHUT DOWN. THE BATTERY WAS REPLACED AND THE DEVICE TURNED ITSELF OFF AGAIN AFTER TWO MINUTES. IT WAS FURTHER REPORTED THAT THE BATTERY WAS TOO SMALL THUS NOT ALLOWING SUFFICIENT CONTACT. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258448 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1