BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173627 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11823
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT LOOKED AT THE TRENDING DATA AND SUGGESTED TALKING TO THIS PATIENT'S PHYSICIAN TO DETERMINE IF THE BONE STIMULATOR CAN BE TURNED OFF TO SEE IF SHOCKING LEAD IMPEDANCE MEASUREMENTS NORMALIZE. THE CONSULTANT DISCUSSED THIS TEST IS HIGHLY SENSITIVE TO ELECTROMAGNETIC INTERFERENCE (EMI). HOWEVER, THEY CANNOT RULE OUT A SHORTED SHOCKING LEAD AND IF THE MEASUREMENTS DO NOT NORMALIZE, FURTHER TESTING WILL BE REQUIRED FOR PATIENT SAFETY. THE CONSULTANT REVIEWED THE DEVICE DATA AND NOTED THE LAST CAPACITOR REFORMATION WAS ON (B)(6) 2011. IT WAS ALSO NOTED THAT WHEN A REAL SHOCK WAS DELIVERED, IT WAS OKAY WITH NORMAL IMPEDANCE MEASUREMENTS OBSERVED. NOISE WAS NOTED ON ALL THREE CHANNELS. HOWEVER, NO OVERSENSING WAS OBSERVED EXCEPT DURING THE LUMBAR SURGERY ON (B)(6) 2011. THE CONSULTANT SUGGESTED REVIEWING THE NEXT CAPACITOR REFORMATION AND TO CONSIDER PERFORMING AN INDUCTION TO PROVE THERE IS NO INTERACTION WITH DEFIBRILLATION TESTING (DFT). THE CALLER WILL DISCUSS THE ISSUES FURTHER WITH THIS PATIENT'S PHYSICIAN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-VALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD UNDERGONE LUMBAR SURGERY AND IS USING A BONE STIMULATOR WHICH IS CAUSING RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCES TO DECREASE. A RED ALERT WAS DISPLAYED FOR SHOCKING IMPEDANCE LESS THAN 20 OHMS AND NOISE WAS OBSERVED. THE PATIENT PERFORMED ANOTHER PATIENT INITIATED INTERROGATION (PII) WITH THE BONE GROWTH STIMULATOR TURNED OFF AND SHOCKING IMPEDANCE WAS NORMAL AT 45 OHMS. THE PATIENT IS IMMOBILIZED AND CANNOT COME INTO THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4470| 0185| N119| 4555