BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152136 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00518
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS BROKEN. ANALYSIS DID FIND THAT THE LCD LENS WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE LOWER CASE WAS OUT OF SPECIFICATION, THE TWO SIDE BAIL COVERS WERE BROKEN AND THE RING WAS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A BROKEN LIQUID CRYSTAL DISPLAY (LCD). 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 BROKEN LIQUID CRYSTAL DISPLAY (LCD). 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
    252807 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1