BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952615 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00133
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE PROGRAMMER WAS RETURNED AND ANALYSIS DID CONFIRM THE CUSTOMER COMMENT THAT THE UNIT BOOTED UP VERY SLOWLY, BUT WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE FAN QUIT WORKING. ANALYSIS DID FIND A MISSING KEYBOARD SCREW MOVING FREELY INSIDE THE POWER SUPPLY WHICH MAY HAVE INTERFERED WITH THE OPERATION OF THE POWER SUPPLY AND A LOOSE ELECTROCARDIOGRAM (ECG) CONNECTOR, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN OF THE EXTERNAL PULSE GENERATOR WAS CRACKED. 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 SCREEN OF THE EXTERNAL PULSE GENERATOR WAS CRACKED. 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
    55636 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1