BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE G ACTIVE FIX DUAL COIL 64CM

    MDR report key: 1684468 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-05979
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    March 8, 2010
    Report Date
    November 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE 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 CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) RATE/SENSE CHANNEL, WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION. IT WAS NOTED THAT THE PATIENT WAS IN THE CASINO AT THE TIME. THE NOISE WAS UNABLE TO BE RECREATED WITH POCKET MANIPULATION OR ISOMETRICS, AND ALL LEAD MEASUREMENTS WERE NORMAL BY REPORT. TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF ELECTRO MAGNETIC INTERFERENCE (EMI) OR DIAPHRAGMATIC OVERSENSING. TS HAD PREVIOUSLY DISCUSSED PROGRAMMING THE RV SENSITIVITY TO LEAST; IT WAS NOTED THAT THE RV SENSITIVITY WAS AT LEAST. ADDITIONALLY, IT WAS QUESTIONED WHY THERE WAS AN RV SENSE SIGNAL DURING LEFT VENTRICULAR (LV) THRESHOLD TESTING AND RATE CHANGE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION WAS PROVIDED THAT NOISE WAS AGAIN OBSERVED ON THE RV CHANNEL, WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION. OUT OF RANGE RV IMPEDANCES WERE ALSO NOTED; HOWEVER, IT WAS UNKNOWN WHETHER THEY WERE HIGH OR LOW. IT WAS NOTED THAT THE PATIENT WAS BROUGHT IN TO THEIR CLINIC AND ALL LEAD DIAGNOSTICS WERE NORMAL. NOISE WAS ABLE TO BE RECREATED WITH PATIENT ISOMETRICS AND VALSALVA. TS DISCUSSED TROUBLESHOOTING STEPS TO HELP FIGURE OUT IF THIS WAS A CONNECTION ISSUE OR A LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD MEASUREMENTS WERE STABLE WITH NO SIGNS OF A LEAD OR CONNECTION ISSUE. THE PHYSICIAN REVIEWED THE PATIENT'S LATITUDE INFORMATION AND NOTED THE NOISE LOOKED LIKE MYOPOTENTIAL IN NATURE. TS DISCUSSED OPTIONS OF CHANGING SENSITIVITIES IN THE RV. IT WAS ADDITIONALLY NOTED THAT DIAPHRAGMATIC OVERSENSING WAS CONFIRMED AND THE PATIENT WAS SCHEDULED FOR TESTING OF SENSITIVITY SETTINGS. THE PATIENT WAS REPORTED TO HAVE AN UNDERLYING RHYTHM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT ELECTROGRAMS (EGMS) FOR THIS PATIENT WERE BEING REVIEWED AND DIAPHRAGMATIC NOISE WAS AGAIN OBSERVED ON THE RV CHANNEL. THE NOISE WAS RESULTING IN THE STORAGE OF NON SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) AND THE PHYSICIAN WAS QUESTIONING THE PATIENT RATE DURING THESE EPISODES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE EPISODES AND NOTED THE GAP THE CLINIC WAS SEEING ON THE PATIENT'S DATA FROM THEIR REMOTE MONITORING SYSTEM WAS JUST A FUNCTION OF THE REMOTE MONITORING DISPLAY AND WAS NOT A GAP IN TIME. IT WAS ALSO NOTED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING HAD BEEN DONE FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE G ACTIVE FIX DUAL COIL 64CM IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R DEVICE H170/(B)(4)