BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2964644 · Received February 15, 2013

    Report

    Report Number
    2135394-2013-00004
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOTE MONITOR WOULD DIAL OUT DURING THE TRANSMISSION PROCESS, BUT WOULD NOT COMPLETE THE TRANSMISSION. IT WAS FURTHER REPORTED THAT THE BATTERY HAD "EXPLODED" INSIDE THE MONITOR. THE PATIENT HAD ALREADY CLEANED UP THE MESS THE BATTERIES MADE, BUT THE MONITOR WOULD NOT SEND THE TRANSMISSION PROPERLY AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66286 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MILACA INC. 2490H

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR