BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041720 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02089
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT ISSUE RESULTED AROUND A LOOSE SET SCREW WHICH WAS RESOLVED IN A REVISION PROCEDURE. NOTHING FURTHER WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN IN SERVICE. 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 RECEIVED INFORMATION FROM A NON-BOSTON SCIENTIFIC REPRESENTATIVE THAT A NON-BOSTON SCIENTIFIC DEVICE DETECTED SHOCK IMPEDANCES AROUND 62 OHMS. HOWEVER, AS OF RECENT THE MEASUREMENTS WERE >200 OHMS. TROUBLESHOOTING RESULTED IN THE SAME MEASUREMENTS. NO NOISE WAS PRESENT. THE PATIENT WAS TO BE SENT FOR A CHEST X-RAY. NO PATIENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 185 MO 0180| (B)(4)| MISMATCH