BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2953519 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00187
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. CORROSION WAS FOUND IN THE BATTERY COMPARTMENT DUE TO BATTERY LEAKAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAN'T GET PAST THE THIRD TELEMETRY LIGHT WITH THE PREVIOUSLY WORKING REMOTE MONITOR. THE PATIENT IS RETURNING THE MONITOR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57332 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MILACA, INC. 2490H

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR