BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163343 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07989
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 20, 2011
    Report Date
    July 30, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES REPRESENTATIVE DISCUSSED SEVERAL STORED EPISODES ON THE SAVE TO DISK. NOISE WAS SEEN ON THE RIGHT VENTRICULAR PACE/SENSE AND SHOCK CHANNELS. THE NOISE APPEARS TO BE IRREGULAR AND INTERMITTENT. IN ADDITION SOME OVERSENSING WAS OBSERVED DUE TO NOISE. TECHNICAL SERVICES NOTED THAT PACING INHIBITION FOR > 2 SECONDS MAY HAVE OCCURRED DUE TO NOISE AND OVERSENSING. TECHNICAL SERVICES DISCUSSED SEVERAL INDICATIONS FOR NOISE SUCH AS LEAD AND DEVICE CONNECTION OR A POSSIBLE LEAD ON LEAD CONTACT RESULTING IN THE REPORTED CLINICAL OBSERVATION. ADDITIONAL INFORMATION PROVIDED NOTED THAT NO NOISE WAS SEEN SINCE IMPLANT AND NOISE WAS ONLY SEEN POST SHOCK. IN ADDITION IT WAS CONFIRMED BY A BOSTON SCIENTIFIC REPRESENTATIVE THAT THERE WAS NO LEAD ON LEAD CONTACT. A POSSIBLE LOOSE CONNECTION WAS SUSPECTED.

    Additional Manufacturer Narrative · 1

    A DATA DISK WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER TECHNICAL ANALYSIS. A TS CONSULTANT REVIEWED THE DATA AND DISCUSSED THAT THE OBSERVED NOISE MORPHOLOGY WAS MECHANICAL AND INDICATIVE OF LEAD COMING IN CONTACT WITH ONE ANOTHER DUE TO MOTION OF THE HEART. THE NOISE APPEARED POST-SHOCK BUT RANDOMLY IN THE CARDIAC CYCLE AND AT A HIGH FREQUENCY. IN ADDITION, THE TS CONSULTANT DISCUSSED THAT THE DURATION WAS ALSO SHORT WHICH IS EXPECTED IN CASES OF LEAD-ON-LEAD CONTACT. HOWEVER, NOISE AS A RESULT OF UNDERINSERTION COULD ALSO HAVE PRODUCED SIMILAR NOISY SIGNALS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY FOUND BLOOD IN THE LUMEN WHICH HAD POSSIBLY ENTERED THROUGH THE TERMINAL PIN OR BY THE WAY OF THE STYLET. THE LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT BOTH THE DEVICE AND LEAD WAS EXPLANTED AND REPLACED WITH COMPETITOR PRODUCTS. THE SYSTEM WILL BE RETURNED. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A WHOLE COMPETITOR UNIT WAS EXPLANTED DUE TO A COMPETITOR LEAD RIGHT VENTRICULAR LEAD FRACTURE. THE COMPETITOR LEAD REMAINED IN THE RIGHT VENTRICLE. A NEW RIGHT VENTRICULAR LEAD AND DEVICE WERE IMPLANTED IN THE PATIENT. DURING DEFIBRILLATION TESTING NOISE WAS SEEN ON THE VENTRICULAR CHANNEL AFTER A SHOCK. THE NOISE SPORADICALLY DISAPPEARED AND WAS NO LONGER SEEN ON THE SHOCKING CHANNEL. IN ADDITION PACING IMPEDANCES HAD DECREASED. THE PHYSICIAN INQUIRED TO BOSTON SCIENTIFIC TECHNICAL SERVICES THE REASON THAT THE NOISE WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R