BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951494 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00035
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE BATTERY FLEX WAS CONTAMINATED, THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY RELEASE, BATTERY DRAWER, LEAD FLEX COVER, BATTERY CONTACTS AND KEYBOARD PAD WERE CONTAMINATED, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, AND THE RING AND TWO SIDE BAILS WERE MISSING. FURTHER ANALYSIS WAS PERFORMED ON THE PCB. THIS ANALYSIS FOUND THAT A TRANSISTOR COMPONENT HAD FAILED ON THE PCB, FURTHER CONFIRMING THE FAILURE MODE. (B)(4).

    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 CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE BATTERY FLEX WAS CONTAMINATED, THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY RELEASE, BATTERY DRAWER, LEAD FLEX COVER, BATTERY CONTACTS AND KEYBOARD PAD WERE CONTAMINATED, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, AND THE RING AND TWO SIDE BAILS WERE MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT POWER UP. THE BATTERY VOLTAGE WAS MEASURED AT 9.8 VOLTS. THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT POWER UP. THE BATTERY VOLTAGE WAS MEASURED AT 9.8 VOLTS. THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56544 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1