BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951517 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00020
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE GENERATOR WAS NOT "TRIGGERING" CORRECTLY. ANALYSIS DID FIND THAT THE RING COVER WAS BROKEN. (B)(6). (B)(4).

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS "TRIGGERING INCORRECTLY". THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THE CALLER HAD NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS "TRIGGERING INCORRECTLY". THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THE CALLER HAD NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55467 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1