BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK PLUS

    MDR report key: 2153606 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06392
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 17, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    HALF OF THIS LEAD WAS EXPLANTED. THE REST OF THE LEAD WILL BE REMOVED AT A LATER DATE FROM A SURGICAL APPROACH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL ANALYSIS WAS PERFORMED ON THE LEAD. THE LEAD WAS SEVERED 14 CENTIMETERS FROM IS-1 PIN, WITH THE PROXIMAL SEGMENT ONLY RETURNED. THE LEAD SEGMENT THEN PASSED A CONTINUITY TEST, WITH NO FURTHER DETAILED ANALYSIS PERFORMED. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS ON THE LEAD SEGMENT AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. HALF OF THIS LEAD WAS EXPLANTED. THE OTHER HALF IS BEING REMOVED ON A FUTURE DATE FORM A SURGICAL APPROACH. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK PLUS IMPLANTABLE LEAD NVY HISTORICAL PUERTO RICO 0115

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R E102| 0115| 1720| 1790| 1860| 4137