BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223584 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10046
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SHOCK THERAPY. INTERROGATION OF THE DEVICE REVEALED A SHOCK LEAD OPEN FAULT MESSAGE. REPORTED SHOCK IMPEDANCE MEASUREMENT WERE 93 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHBITED A FAULT CODE RELATING TO AN OPEN CIRCUIT WHICH WAS DETECTED DURING SHOCK DELIVERY. THE PATIENT RECEIVED SEVERAL APPROPRIATE SHOCKS. SHOCKING LEAD IMPEDANCE WAS 90 OHMS, RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT WAS 490 OHMS AND PACING THRESHOLD MEASUREMENTS WERE FINE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE PATIENT NEEDS TO FOLLOW-UP WITH THE PHYSICIAN BECAUSE BOTH THE DEVICE AND THE LEAD ARE LIKELY TO BE REPLACED. ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THE PATIENT IS BEING TREATED WITH CELLULITIS AND AN E.COLI INFECTION WHICH IS NOT RELATED WITH THE PRODUCT. ALSO, THE PATIENT IS WEARING A LIFEVEST AND THE PATIENT IS ON ANTIBIOTICS FOR SEVERAL WEEKS. AFTER THE PATIENT HAS COMPLETED THE ANTIBIOTIC REGIMEN, THE PATIENT WILL BE SCHEDULED FOR A LEAD EXTRACTION AND DEVICE EVALUATION WITH THE PHYSICIAN. THE RV LEAD REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324216 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R E102| 0184| 1852