BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2203401 · Received August 11, 2011

    Report

    Report Number
    3004593495-2011-00060
    Event Type
    Malfunction
    Date Received
    August 11, 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
    MS, 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): ANALYSIS FOUND THAT THE PRINTED CIRCUIT (PC) BOARD WAS CORRODED AND CONTAMINATED.

    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 THE CARELINK MONITOR WAS NOT RECEIVING POWER. NOTHING HAPPENED WHEN THE START BUTTON WAS PRESSED. 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 PATIENT CALLED AND INDICATED THAT WHEN THE START BUTTON IS PUSHED ON THE CARELINK MONITOR, IT DOES NOT BEGIN TO "READ." THE MONITOR WAS WORKING PREVIOUSLY. A NEW MONITOR WILL BE SENT TO THE PATIENT. NO PATIENT COMPLICATIONS WERE 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 46 YR Other 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB