BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952517 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00121
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THAT THE LIQUID CRYSTAL DISPLAY (LCD) LENS WAS BROKEN, THOUGH THE DISPLAY ITSELF WAS NOT. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING AND SIDE BAIL COVERS WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING BAIL WAS BENT AND THE BATTERY DRAWER WAS CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LCD GLASS DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) WAS BROKEN. THE EPG WAS SENT IN FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LCD GLASS DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) WAS BROKEN. THE EPG WILL BE SENT IN FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56208 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1