BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151572 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00502
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LOWER CASE WAS BROKEN BUT WAS UNABLE TO CONFIRM THE COMMENT THAT THE DISPLAY DID NOT WORK. ANALYSIS ALSO FOUND THE UPPER CASE AND BOTH BAIL COVERS WERE BROKEN, THE RING COVER AND RING WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED AND THE LIQUID CRYSTAL DISPLAY (LCD) WAS "BLEEDING." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A CRACKED REAR CASE AND THAT THE DISPLAY DID NOT WORK. IT WAS FURTHER REQUESTED THAT THE UNIT'S INTERNAL COMPONENTS AND OUTPUT BE CHECKED. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A CRACKED REAR CASE AND THAT THE DISPLAY DID NOT WORK. IT WAS FURTHER REQUESTED THAT THE UNIT'S INTERNAL COMPONENTS AND OUTPUT BE CHECKED. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252220 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1