BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3862365 · Received June 10, 2014

    Report

    Report Number
    3004593495-2014-00021
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2013; 5076-45 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE MONITOR WAS ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHILE USING THE REMOTE MONITORING TRANSMISSION HOME MONITOR, WHILE ON THE THIRD LIGHT ON THE READING PHASE, THE PATIENT AND THE PATIENT'S DAUGHTER-IN-LAW FELT A SHOCK. THE DAUGHTER-IN-LAW HAD BEEN HELPING THE PATIENT WITH THE TRANSMISSION. THE PATIENT REPORTED BEING FINE AFTER THE TRANSMISSION WAS COMPLETE. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE CONFIRMED THAT THE DAUGHTER-IN-LAW DID NOT HAVE ANY SERIOUS INJURIES, AND THAT BOTH PATIENT AND DAUGHTER-IN-LAW HAVE REPORTED THAT THEY ARE "FINE." THE PATIENT WAS TO BE SENT A NEW MONITOR, AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337826 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD 2490H9

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Life Threatening ADDRL1 IPG