BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951708 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00055
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 20, 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 EXTERNAL PULSE GENERATOR WAS RETURNED AND ANALYSIS DID NOT CONFIRM THE CUSTOMER COMMENT THAT THE RATE KNOB DID NOT WORK. ANALYSIS DID FIND THAT THE LOWER CASE WAS BROKEN AND CONTAMINATED, THAT ONE BAIL COVER WAS BROKEN AND ONE WAS CONTAMINATED, TWO CASE SCREWS WERE MISSING, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED AND THE SERIAL NUMBER LABEL WAS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE KNOB ON THE EXTERNAL PULSE GENERATOR DID NOT WORK. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE KNOB ON THE EXTERNAL PULSE GENERATOR DID NOT WORK. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55696 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1