BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2120824 · Received June 11, 2011

    Report

    Report Number
    3004593495-2011-00002
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    March 24, 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
    OH, 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.

    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 MONITOR WOULD NOT START AN INTERROGATION. FURTHER ANALYSIS FOUND THAT THERE WAS CORROSION AND CONTAMINATION ON THE PRINTED CIRCUIT BOARD ASSEMBLY, THIS WAS THE CAUSE OF THE MONITOR NOT BEING ABLE TO POWER UP.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: A CORRECTION TO MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8.

    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 WHEN THE START BUTTON ON THE REMOTE MONITOR WAS PRESSED IT FAILED TO POWER UP. THE POWER BUTTON WAS LIT, BUT NO ADDITIONAL INDICATOR LIGHTS CAME ON AND NO TELEMETRY WAS INITIATED. THE MONITOR HAD TRANSMITTED SUCCESSFULLY IN THE PAST. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT IS TRYING TO TRANSMIT, THE POWER LIGHT IS ON, BUT NO OTHER LIGHTS COME ON WHEN THE START BUTTON IS PRESSED. 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 THAT WHEN THE PATIENT IS TRYING TO TRANSMIT, THE POWER LIGHT IS ON BUT NO OTHER LIGHTS COME ON WHEN THE START BUTTON IS PRESSED. 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 80 YR Other 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB