BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2911905 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16316
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    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

    AS THE LEAD WAS NOT ABLE TO BE RETURNED FOR ANALYSIS, CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) PACING LEAD WAS HOSPITALIZED FOR A NON-DEVICE RELATED ISSUE. WHILE IN THE HOSPITAL, PACING FAILURE WAS OBSERVED ON THE ELECTROCARDIOGRAM (ECG) MONITOR. THE DEVICE WAS INTERROGATED WITH A PROGRAMMER AND THE RV LEAD PACING IMPEDANCE WAS GREATER THAN 3,000 OHMS. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS DISCONNECTED FROM THE DEVICE AND TESTED ON THE PACING SYSTEM ANALYZER (PSA), WITH PACING IMPEDANCE MEASUREMENTS OF 450 OHMS. A LEAD FRACTURE WAS STILL SUSPECTED, SO THE LEAD WAS SURGICALLY ABANDONED. A NEW COMPETITIVE RV LEAD WAS IMPLANTED, AND THE COMPETITIVE DEVICE WAS ALSO REPLACED WITH ANOTHER COMPETITIVE DEVICE. THE PHYSICIAN SUSPECTED AN INCOMPLETE LEAD FRACTURE AT THE PUNCTURE SITE, AS THE PUNCTURE WAS MADE VERTICALLY FOR LEAD INSERTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16452 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4377

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R