BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151635 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00575
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS DID CONFIRM THE CUSTOMER COMMENT THAT AFTER POWERING DOWN THE GENERATOR'S PACE AND SENSE LIGHT-EMITTING DIODES (LED'S) REMAINED ON AND IT WAS ATTRIBUTED TO THE MAIN PRINTED CIRCUIT BOARD (PCB) BEING OUT OF SPECIFICATION. ANALYSIS ALSO FOUND THE UPPER CASE, TWO SIDE BAIL COVERS AND THE BATTERY DRAWER BROKEN, THE LOWER CASE BROKEN AND CONTAMINATED, THE RING COVER AND KEYBOARD PAD CONTAMINATED, THE BATTERY CONTACTS COMPRESSED AND THE RING BENT. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS WAS UNABLE TO REPRODUCE THE FAILURES SEEN DURING INITIAL REPAIR OF THE DEVICE. THERE WAS CONTAMINATION WITHIN THE UNIT. IT IS LIKELY THIS MAY HAVE BEEN RESPONSIBLE FOR THE REPORTED FAILURES, THE MAIN PCB IS WITHIN OPERATIONAL SPECIFICATION.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER POWERING DOWN THE EXTERNAL PULSE GENERATOR'S PACE AND SENSE LIGHT-EMITTING DIODE (LED) REMAINED ON. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252226 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1