BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 3913461 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12069
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    March 3, 2014
    Report Date
    June 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TWISTING MARKS, WHICH USUALLY INDICATE OVER-TORQUE OF THE HELIX, WERE NOT OBSERVED ON THE LEAD BODY AND THE HELIX WAS NOTED TO BE FULLY RETRACTED. VISUAL ANALYSIS DID SHOW THAT THE LEAD WAS FRACTURED IN THE INNER COIL AT THE DISTAL END OF TERMINAL PIN. X-RAY WAS ALSO PERFORMED AND CONFIRMED THE ISSUE. NO OTHER TEST WAS DONE DUE TO THE OBSERVATION. IT WAS CONCLUDED THAT THE LEAD WAS CLINICALLY OUT OF SPECIFICATIONS DUE TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PHYSICIAN WAS UNABLE TO EXTRACT THE HELIX OF THIS RIGHT ATRIAL (RA) LEAD. THE PHYSICIAN ATTEMPTED SEVERAL TIMES BUT STILL UNSUCCESSFUL. ANOTHER LEAD WAS IMPLANTED SUCCESSFULLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO HANDLE THE LEAD AND SCREW MECHANISM WITH CAUTION. THIS RA LEAD WAS NEVER IN SERVICE AND WILL BE RETURNED TO LABORATORY FOR DETAILED ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391761 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 4096