BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 3935988 · Received July 15, 2014

    Report

    Report Number
    2124215-2014-13872
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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. THE COMPLETE LEAD WAS RETURNED BUT BENT CLOSE TO THE TERMINAL PIN. VISUAL INSPECTION NOTED THAT THE BLOOD/TISSUE ON THE HELIX AND IT WAS STRETCHED. A STYLET WAS RETURNED WITH THE LEAD THAT WAS NOT MANUFACTURED BY BOSTON SCIENTIFIC. THE STYLET WAS BENT AND CURVED WHEN IT WAS REMOVED FROM THE LEAD BODY. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND REVEALED AN OPEN CIRCUIT CONDITION ON THE CATHODE. X-RAYS OF THE LEAD WERE TAKEN AND CONFIRMED THAT THE LEAD HAD FRACTURED. IT ALSO REVEALED THAT THE STYLET WAS NOT COMPLETED SEATED IN THE ELECTRODE TIP. IN ADDITION, THE INSULATION WAS TWISTED IN THREE LOCATIONS ALONG THE LEAD BODY. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN DISCOVERED THAT THERE WAS MEDICAL ADHESIVE IN THE INNER AND OUTER PORTIONS OF THE TERMINAL PIN ASSEMBLY. DUE TO THE TYPE OF DAMAGE NOTED WITH THIS LEAD, ANALYSIS CONCLUDED THAT THIS RA LEAD FRACTURED WHEN ATTEMPTING TO EXTEND/RETRACT THE HELIX DURING THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REVISION TO REPOSITION ANOTHER LEAD, THIS RIGHT ATRIAL (RA) LEAD DISLODGED. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE HELIX, IT WOULD NOT MOVE. THE RA LEAD WAS SUCCESSFULLY REPLACED AND WAS RETURNED FOR LABORATORY ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413432 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 4096| 7741| 4554| F143| 0181