BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2605882 · Received June 8, 2012

    Report

    Report Number
    2183613-2012-00881
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    March 6, 2012
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE MONITOR WAS ANALYZED AND NO ANOMALIES WERE FOUND. BENCH POWER TEST PASSED, FULL DEBUG MODE TEST PASSED, POWER ADAPTOR TESTING PASSED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PREVIOUSLY WORKING REMOTE MONITOR, DID NOT POWER ON EVEN AFTER SETUP WAS VERIFIED. THE POWER CORD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PREVIOUSLY WORKING REMOTE MONITOR, DID NOT POWER ON EVEN AFTER SETUP WAS VERIFIED. THE POWER CORD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 5076 IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD