BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152257 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00692
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE OUTPUT READINGS DID NOT MATCH THE SETTINGS. ANALYSIS DID FIND THAT THE DEVICE WOULD NOT TURN ON WITH THE FIRST PRESS OF THE BUTTON WHICH WAS ATTRIBUTED TO THE MAIN PRINTED CIRCUIT BOARD BEING OUT OF SPECIFICATION AND THEREFORE IT WAS REPLACED, AND THAT THE BATTERY CONTACTS WERE COMPRESSED. (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. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS COULD NOT CONFIRM THE REPORT OF OUT OF SPECIFICATION VENTRICULAR OUTPUT AND BATTERY CURRENT DRAIN. HOWEVER THE OUT OF SPECIFICATION ON BUTTON OPERATION WAS CONFIRMED, THIS WAS CAUSED BY A SOLDER DEFECT AT AN INTEGRATED CIRCUIT COMPONENT. SHUTDOWN FAILURE WAS CONFIRMED CAUSED BY THE INTEGRATED CIRCUIT COMPONENT FAILURE.

    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 DURING BENCH TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE VENTRICULAR MAXIMUM OUTPUT READING WAS LOWER THAN WHAT IT WAS SET TO. IT WAS FURTHER NOTED ON THE RETURN PAPERWORK THAT CURRENT DRAIN READINGS FOR THE GENERATOR WERE UNABLE TO BE OBTAINED, AND THAT ITS TEST AND CALIBRATION WAS REQUESTED. THE EPG HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BENCH TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE VENTRICULAR MAXIMUM OUTPUT READING WAS LOWER THAN WHAT IT WAS SET TO. IT WAS FURTHER NOTED ON THE RETURN PAPERWORK THAT CURRENT DRAIN READINGS FOR THE GENERATOR WERE UNABLE TO BE OBTAINED, AND THAT ITS TEST AND CALIBRATION WAS REQUESTED. THE EPG HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BENCH TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE VENTRICULAR MAXIMUM OUTPUT READING WAS LOWER THAN EXPECTED. THE EPG WILL BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252405 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1