BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152068 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00531
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; BOARD FLEX CABLE FOUND LOOSE ON THE CONNECTOR ON THE LCD (LIQUID CRYSTAL DISPLAY). IT IS NOTED DUE TO THE ABUSE OF THE DEVICE, THE BOARD CONNECTOR CABLE WAS JARRED FROM THE CONNECTOR ON LCD DISPLAY MAKING A BAD CONNECTION. ANALYSIS ALSO FOUND THE UPPER CASE, LOWER CASE, ONE CONTROL KNOB, TWO SIDE BAIL COVERS, AND THE BATTERY DRAWER ARE BROKEN. BATTERY RELEASE, RING COVER AND LEAD FLEX COVER ARE CONTAMINATED. ONE CASE SCREW FOUND TO BE INCORRECT. BATTERY CONTACTS COMPRESSED. ONE SIDE BAIL MISSING AND THE RING IS BENT. MAIN PRINTED CIRCUIT BOARD FOUND OUT OF ELECTRICAL 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

    FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THIS ANALYSIS COULD NOT CONFIRM THE PCB FAILURE FOUND DURING SERVICE AND REPAIR OF THE DEVICE, HOWEVER, ATYPICAL ERROR MESSAGES WERE CONFIRMED CAUSED BY A CORRUPTED INTEGRATED CIRCUIT COMPONENT EEPROM (ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY) PROGRAMMING. PERFORMING CALIBRATION RESTORED THE DEVICE TO TYPICAL OPERATION.

    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 THERE WERE DISPLAY PROBLEMS. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252248 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1