BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212431 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08646
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING AND NOISE RESULTING IN PACING INHIBITION AND ASYSTOLE GREATER THAN TWO SECONDS. THIS RESULTED IN AN INAPPROPRIATE 41 JOULE SHOCK. THE PATIENT WITH THIS DEVICE HAS AN INTRINSIC ESCAPE RHYTHM OF APPROXIMATELY THIRTY BEATS PER MINUTE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND REQUESTED A SAVE TO DISK BE PERFORMED AND ADDITIONAL INFORMATION. IF NO FURTHER EPISODES HAVE BEEN STORED, PROGRAMMING OF EXTENDING THE DURATION SENSITIVITY MAY RESOLVE THE ISSUE AND IF EVALUATION OF THE SENSITIVITY IS NOT POSSIBLE, PERFORMING DEFIBRILLATION THRESHOLD (DFT) TESTING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE INFORMATION WAS PROVIDED TO THE PHYSICIAN AND A DECISION HAS BEEN MADE TO FURTHER MONITOR THIS SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. TS REVIEWED THE SAVE TO DISC AND DETERMINED THAT AS THERE APPEARS TO BE ARTIFACT ON THE BASELINE OF ALL THREE CHANNELS, THE MOST LIKELY CONCLUSION IS SOME FORM OF EXTERNAL ELECTROMAGNETIC INFERENCE SOURCE CAUSED/CONTRIBUTED TO THE EPISODE. SOME UNDERSENSING THAT DID NOT RESULT IN ANY DELAY TO DETECTION OR TO THERAPY. NORMAL FOLLOW UP WAS RECOMMENDED AND PROGRAMMING OPTIONS WERE PROVIDED TO DISCUSS WITH THE PHYSICIAN. THESE RECOMMENDATIONS WILL BE PROVIDED TO THE PHYSICIAN AND THIS SYSTEM WILL BE FURTHER MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313474 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR 1290| N107| 4554| 0175| 4457| 4480