BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131323 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00906
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S154
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PERFORMANCE EVALUATION (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE CARELINK MONITOR WAS UNABLE TO COMPLETE THE SEND PHASE OF THE REMOTE TRANSMISSION. THE MONITOR WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE CARELINK MONITOR IS UNABLE TO COMPLETE THE SEND PHASE OF THE REMOTE TRANSMISSION. THE MONITOR WILL BE 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 PLEXUS MANUFACTURING SDN. BHD. 2490C8 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD