BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3920061 · Received July 8, 2014

    Report

    Report Number
    2124215-2014-13629
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ONGOING. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SENT BACK TO THE MANUFACTURING PLANT FOR FURTHER EVALUATION. ANALYSIS CONCLUDED THAT THIS LEAD MET ALL SPECIFICATIONS DURING TESTING. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REVIEW OF MANUFACTURING TEST RECORDS FOR ENDOTAK RELIANCE LEADS REVEALED A SUSPECTED TEST DATA RECORDING ERROR. SPECIFICALLY, SOME TEST RESULTS WERE RECORDED AS ¿FAILED¿ WITHOUT ANY OTHER INDICATION OF FAILURE. THE ERROR WAS NOT DETECTED PRIOR TO THE DEVICES BEING PLACED INTO THE DISTRIBUTION CHANNEL. AS A PRECAUTIONARY MEASURE, BOSTON SCIENTIFIC IS RETRIEVING THE DEVICES WITHIN OUR CONTROL AND HAS ASKED SALES REPRESENTATIVES TO RETRIEVE THE DEVICES FROM HOSPITAL INVENTORY AND RETURN THEM TO THE MANUFACTURING PLANT. THIS RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY RETRIEVED FROM THE HOSPITAL TO WHICH IT WAS SOLD AND WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395866 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1