BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA 700 SR

    MDR report key: 4163215 · Received October 10, 2014

    Report

    Report Number
    2647346-2014-00084
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE HOSPITAL WITH SYNCOPE. THE DEVICE COULD NOT BE INTERROGATED AND WAS UNRESPONSIVE TO MAGNET APPLICATION. THE DEVICE IS SUSPECT TO BE AT END OF LIFE (EOL). THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO SENSE ANY R-WAVES EVEN THOUGH THE ELECTROCARDIOGRAM MONITOR SHOWED THAT THE PATIENT HAD AN UNDERLYING INTRINSIC RHYTHM. THE RV LEAD WAS FOUND TO HAVE LOW PACING IMPEDANCE. THE LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644542 KAPPA 700 SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL KSR703

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 4004-58 LEAD