BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952084 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00075
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MILACA MANUFACTURING INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN AND CONTAMINATED, THE RING COVER WAS BROKEN, THE RING WAS MISSING, THE BATTERY DRAWER WAS OUT OF SPECIFICATION.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR DID NOT TURN ON. IT WAS FURTHER NOTED THAT THE GENERATOR WAS ON LOAN TO THE HOSPITAL. THE GENERATOR WAS RETURNED TO SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56121 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MILACA MANUFACTURING INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1