BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131407 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00212
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S102
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) - THE REMOTE MONITOR WAS RETURNED FOR ANALYSIS. VISUAL AND FUNCTIONAL ANALYSIS WAS COMPLETED AND THE CUSTOMER COMMENT WAS CONFIRMED. THE MONITOR LIGHT-EMITTING DIODES WOULD FLASH UPON START UP. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT FOLLOWING STORMS THE REMOTE MONITOR WAS NO LONGER WORKING CORRECTLY. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AFTER A STORM THE CARELINK MONITOR (CLM) IS NOT WORKING CORRECTLY. THE CLM IS BEING REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT NVZ MEDTRONIC MILACA INC. 2490C ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other 6943 IMPLANTABLE TACHY LEAD| PHONECORD PATIENT MONITORING ACCESSORY| POWERCORD PATIENT MONITORING ACCESSORY| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6943 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6943 IMPLANTABLE TACHY LEAD| PHONECORD PATIENT MONITORING ACCESSORY| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB