BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211081 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10073
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. VISUAL INSPECTION OF THE LEAD REVEALED A SEPARATION OF THE GORE COVERING FROM THE MEDICAL ADHESIVE (MA) AT THE PROXIMAL EDGE OF THE PROXIMAL SHOCKING COIL. ASSOCIATED WITH THIS WAS A SLIGHT STRETCHING OF THE PROXIMAL END OF THIS SHOCKING COIL. THE SEPARATION WAS A RESULT OF EXCESSIVE DRAG ON THE GORE AND THE SHOCKING COILS. UNDER NORMAL CIRCUMSTANCES, SEPARATION OF THE GORE COVERING WILL NOT IMPACT THE FUNCTIONALITY OF THE LEAD. MICROSCOPIC INSPECTIONS OF THE ELECTRODE TIP AND HELIX FOUND NO ANOMALIES WHICH WOULD LEAD TO DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE THIS IMPLANTABLE DEFIBRILLATION LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED DURING THE PROCEDURE. APPROXIMATELY, A WEEK LATER THIS LEAD EXHIBITED LOSS OF CAPTURE AND WAS FOUND TO HAVE DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310938 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R N119| 5076| 4543| 4555| 0185| N161| MISMATCH| 5092