BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951487 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00010
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS COULD NOT CONFIRM THE INITIAL ANALYSIS DURING THE REPAIR OF THE DEVICE. RATHER THE INITIAL TEST FAILURES WERE DUE TO CALIBRATION. ONCE THE UNIT WAS CALIBRATED, IT PASSED TESTING.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYZED AND THE CUSTOMER COMMENT "PERIODICALLY WOULD NOT SHUT OFF" WAS CONFIRMED. THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION AND REPLACED. ANALYSIS ALSO FOUND THAT THE UPPER CASE HAD STRESS CRACKS, THE LOWER CASE, HEARTWIRE BLOCK AND RING COVER WERE BROKEN AND THAT THE RING WAS BENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BE) REPORTED THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), IT WAS OBSERVED THAT PERIODICALLY THEY WERE UNABLE TO TURN OFF THE DEVICE. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BE) REPORTED THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), IT WAS OBSERVED THAT PERIODICALLY THEY WERE UNABLE TO TURN OFF THE DEVICE. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE GENERATOR WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56453 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1