BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2120840 · Received June 11, 2011

    Report

    Report Number
    3004593495-2011-00016
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S154
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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.

    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 MONITOR WAS ANALYZED AND NO ANOMALIES WERE FOUND. MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE CLINIC HAS NEVER RECEIVED AN AUTOMATIC, SCHEDULED TRANSMISSION FROM THE CARELINK MONITOR, THOUGH IT DOES SEND MANUAL TRANSMISSIONS SUCCESSFULLY. 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 CARELINK MONITOR (CLM) HAS NEVER BEEN ABLE TO SEND WIRELESS TRANSMISSIONS ONLY MANUAL TRANSMISSIONS. THE CLM HAS NEVER SENT A CARE ALERT. THE CLM 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 THE CARELINK MONITOR (CLM) HAS NEVER BEEN ABLE TO SEND WIRELESS TRANSMISSIONS ONLY MANUAL TRANSMISSIONS. THE CLM HAS NEVER SENT A CARE ALERT. 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 DXY PLEXUS MANUFACTURING SDN. BHD. 2490C8 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| PHONECORD PATIENT MONITORING ACCESSORY| 6949 IMPLANTABLE TACHY LEAD| PHONECORD PATIENT MONITORING ACCESSORY| POWERECORD PATIENT MONITORING ACCESSORY| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| POWERECORD PATIENT MONITORING ACCESSORY