BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952546 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00120
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    August 13, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 DEVICE SHUT OFF DURING USE. ANALYSIS DID FIND THE UPPER AND LOWER CASES BROKEN AND THE SIDE BAIL COVERS AND RING COVER CONTAMINATED. (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 THE DEVICE SHUTS OFF DURING USE EVEN AFTER THE BATTERY WAS CHANGED. IT WAS ALSO REPORTED THE DEVICE SHUT OFF TWICE. THE DEVICE WAS RETURNED FOR EVALUATION AND REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SHUTS OFF DURING USE EVEN AFTER THE BATTERY WAS CHANGED. IT WAS ALSO REPORTED THE DEVICE SHUT OFF TWICE. THE DEVICE WAS RETURNED FOR EVALUATION AND REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56509 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1