BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951484 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00017
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 14, 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
    WI, 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 DEVICE SHUT ITSELF OFF. ANALYSIS DID FIND THAT THE UPPER CASE, SIDE BAIL COVERS AND BATTERY DRAWER WERE BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE EXTERNAL PULSE GENERATOR (EPG) SHUT ITSELF OFF EVEN WITH A NEW BATTERY. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE EXTERNAL PULSE GENERATOR (EPG) SHUT ITSELF OFF EVEN WITH A NEW BATTERY. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56423 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1