BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2173191 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11405
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATOIN BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP THE CONFIGURATION WAS CHANGED FROM BIPOLAR TO UNIPOLAR. AN ALERT MESSAGE APPEARED ON THE PROGRAMMER UPON DEVICE INTERROGATION, AND OUT OF RANGE PACING IMPEDANCES WERE SEEN IN THE UNIPOLAR CONFIGURATION. IT WAS REPORTED THAT THE PACING IMPEDANCES HAD BEEN INCREASING AND HAD BEEN OUT OF RANGE FOR A FEW MONTHS. AN X-RAY TAKEN DID NOT REVEAL A LEAD FRACTURE BUT POSSIBLE LEAD BODY DAMAGE WAS SUSPECTED. SUBSEQUENTLY, A REVISION PROCEDURE TOOK PLACE AND WHEN CONNECTING THE LEAD AND CONNECTING IT TO THE PACING SYSTEM ANALYZER (PSA) OUT OF RANGE PACING IMPEDANCES WERE ONCE AGAIN NOTED. THE LEAD WAS CUT AND A NEW LEAD WAS IMPLANTED. THE DEVICE WAS REPLACED ELECTIVELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4372

    Patients

    Seq Age Sex Outcome Treatment
    1