BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2163346 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-08258
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED A SYNCOPAL EPISODE. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED IMPEDANCES GREATER THAN 3,000 OHMS AND LOSS OF CAPTURE. THE LEAD WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION IN WHICH, THE PACING IMPEDANCES WERE 700 OHMS. A CHEST X-RAY WAS PERFORMED WHICH REVEALED NO LEAD DAMAGE AND THE LEAD WAS FULLY INSERTED INDICATING A COMPLETE CONNECTION. THE NEXT DAY, A REVISION PROCEDURE WAS PERFORMED. AS THE COMPETITOR'S DEVICE WAS REMOVED FROM THE POCKET, IT WAS CONFIRMED THAT THE RIGHT VENTRICULAR LEAD HAD BEEN FULLY CONNECTED TO THE DEVICE. IT WAS ATTEMPTED TO EXPLANT THE LEAD, HOWEVER, THE LEAD COULD NOT BE REMOVED AND WAS SURGICALLY ABANDONED. A NEW RIGHT VENTRICULAR LEAD WAS IMPLANTED ON THE SAME SIDE. A LEAD FRACTURE WAS SUSPECTED AROUND THE SUBCLAVIAN AREA AS THE LEAD LIKELY HAD STRESS AT THIS SITE. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ONE WEEK POST PROCEDURE, THE PATIENT CONDITION WAS GOOD AND NO ANOMALIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4376

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R