BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040734 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01065
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EFFORTS CONFIRMED THE PATIENT IN THIS CASE FAILED TO RETURN TO THE MEDICAL FACILITY FOR ADDITIONAL FOLLOW-UPS. THE FIELD REPRESENTATIVE AND ASSOCIATED PHYSICIAN HAD NO FURTHER INFORMATION. IF NEW DETAILS ARE RECEIVED IN THE FUTURE, AN AMENDED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INFORMATION PROVIDED STATED THE PATIENT WOULD RETURN FOR A SYSTEM EVALUATION BEFORE THE NEXT REGULARLY SCHEDULED THREE MONTH VISIT. WHEN NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, INFORMATION INDICATES THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT SYSTEM EVALUATION, A SINGLE LOW OUT OF RANGE SHOCK IMPEDANCE VALUE WAS NOTED. NO INTERVENTION WAS TAKEN AND IT WAS REPORTED THE PATIENT WOULD RETURN IN THREE MONTHS FOR FOLLOW-UP. NO ADVERSE EFFECTS REPORTED AND NO ALLEGATIONS AGAINST THE IMPLANTED PRODUCT. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED FOR RECOMMENDATIONS AND GUIDANCE. INFORMATION WAS PROVIDED INSTRUCTING THE PATIENT TO RETURN AS SOON AS POSSIBLE FOR A LEAD INTEGRITY EVALUATION, AS THE FAULT CODE INDICATED A POTENTIAL COMPROMISED LEAD THAT COULD IMPACT FUTURE DEFIBRILLATION THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1