BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2130539 · Received June 16, 2011

    Report

    Report Number
    2183613-2011-00197
    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
    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. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT. EVALUATION SUMMARY:(B)(4): ANALYSIS FOUND THAT THE PRINTED CIRCUIT (PC) BOARD ASSEMBLY 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. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE PRINTED CIRCUIT (PC) BOARD ASSEMBLY 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.

    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 IS UNABLE TO COMPLETE THE SEND PHASE OF THE TRANSMISSION. HE GETS THE AMBER LIGHT, EVEN WHEN NOT TRYING TO TRANSMIT. THE PATIENT MOVED TO A DIFFERENT PHONE JACK AND RESET THE MONITOR BUT STILL GOT THE AMBER LIGHT. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS WERE 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 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 MEDTRONIC MILACA INC. 2490C ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| POWER CORD PATIENT MONITORING ACCESSORY| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| POWER CORD PATIENT MONITORING ACCESSORY| 6947 IMPLANTABLE TACHY LEAD| PHONECORD PATIENT MONITORING ACCESSORY| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| POWER CORD PATIENT MONITORING ACCESSORY| PHONECORD PATIENT MONITORING ACCESSORY| 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| PHONECORD PATIENT MONITORING ACCESSORY| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD