BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990027 · Received August 7, 2014

    Report

    Report Number
    2183613-2014-01053
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE BATTERY COMPARTMENT WAS CORRODED. THE MONITOR WAS UNABLE TO POWER UP WITH RETURNED AND GOOD BATTERIES. CORROSION CAUSED THE UNIT TO BE UNABLE TO POWER UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOTE MONITOR HAS LIQUID FLUID WHERE THE BATTERIES WERE LOCATED. THE MONITOR 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
    462716 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MILACA, INC. 2490H

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR