BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212428 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09281
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW BY TECHNICAL SERVICES WAS NOTED THAT THE PACING IMPEDANCES HAD GRADUALLY INCREASED UNTIL OUT OF RANGE MEASUREMENTS WERE NOTED (B)(4) 2013. THE SHOCK IMPEDANCES APPEARED CONSTANT OVER TIME AND ARE WITHIN NORMAL RANGE. SOME EPISODES OF NOISE/OVERSENSING WERE NOTED WHICH DID NOT DELIVERED INAPPROPRIATE THERAPY. THE NOISE APPEARS TO BE VERY LOW IN AMPLITUDE AND INTERMITTENTLY ALSO APPEARED ON THE SHOCK CHANNEL. TECHNICAL SERVICES DISCUSSED THAT THE GRADUAL INCREASE IN PACING IMPEDANCES AS WELL AS NOISE OBVERTED WITH LITTLE TO NO CHANGE IN PACING THRESHOLDS COULD BE ATTRIBUTED TO A BUILD UP OF CALCIUM DEPOSITS AT THE INTERFACE OF THE LEAD TIP/HEART TISSUE. FURTHER FOLLOW UP WAS DISCUSSED TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. NO ASYSTOLE FOR GREATER THEN TWO SECONDS WAS NOTED. UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP A GRADUAL RISE IN PACING IMPEDANCES WERE NOTED. THE PACING IMPEDANCES WERE MEASURED OUT OF RANGE WHICH THE ALL OTHER MEASUREMENTS WERE STABLE. IT WAS ALSO NOTED THAT ONE EPISODE OF FALSE VENTRICULAR FIBRILLATION WAS STORED WITH DIVERTED THERAPY, LIKELY CAUSED BY NOISE/OVERSENSING. FURTHER REVIEWED BY THE PHYSICIAN WILL BE PERFORMED TO DETERMINE THE TYPE OF PROCEDURE WHICH WILL TAKE PLACE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313473 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1