BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131410 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00908
    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
    MI, 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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. A CORRECTION WAS MADE TO MFR. SITE ID.

    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 ALL OF THE INDICATOR LIGHTS ON THE CARELINK MONITOR WERE BLINKING AT ONCE. THIS WOULD RECUR ALMOST EVERYDAY. 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 BY THE PATIENT THAT ALL OF THE INDICATOR LIGHTS ON THE CARELINK MONITOR WERE BLINKING AT ONCE. THIS WOULD RECUR ALMOST EVERY DAY. 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 LIGHTS ON THE CARELINK MONITOR (CLM) CONTINUALLY BLINK. THE CLM 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 85 YR Other 4196 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| POWERCORD PATIENT MONITORING ACCESSORY| PHONECORD PATIENT MONITORING ACCESSORY| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD| PHONECORD PATIENT MONITORING ACCESSORY| POWERCORD PATIENT MONITORING ACCESSORY| 6935 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB