BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952672 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00137
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) HAD A CRACKED SCREEN. ANALYSIS DID FIND THE UPPER AND LOWER CASES BROKEN AND CONTAMINATED, THE BATTERY RELEASE CONTAMINATED, BOTH BAIL COVERS BROKEN, TWO CASE SCREWS MISSING, THE BATTERY CONTACTS COMPRESSED, THE RING BENT, THE BATTERY DRAWER BROKEN, THE KEYBOARD OUT OF SPECIFICATION AND THE LCD OUT OF SPECIFICATION (BLEEDING). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)HAD A CRACKED LIQUID CRYSTAL DISPLAY (LCD) SCREEN. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A CRACKED LIQUID CRYSTAL DISPLAY (LCD) SCREEN. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56217 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1