BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2120830 · Received June 11, 2011

    Report

    Report Number
    3004593495-2011-00007
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    April 11, 2011
    Report Date
    September 4, 2015
    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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CORRECTION: A CORRECTION TO MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS DETERMINED NO DEFECT FOUND. THE BENCH POWER-UP TEST PASSED, AND IT WAS VERIFIED THE FULL DEBUG MODE TEST PASSED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TONE WAS GOING OFF ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS A WARNING THAT THE CARELINK MONITOR DID NOT PICK UP THE ICD SIGNAL AND FAILED TO SEND A CARELINK TRANSMISSION. THE DEVICE REMAINS IN USE, AND THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT TONE WAS GOING OFF ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS A WARNING THAT THE CARELINK MONITOR DID NOT PICK UP THE ICD SIGNAL AND FAILED TO SEND A CARELINK TRANSMISSION. THE DEVICE REMAINS IN USE, AND THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD. 2490C8 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| 2187 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD