BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II

    MDR report key: 3905344 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11753
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    December 2, 2013
    Report Date
    May 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. 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 DURING A NON-CARDIAC RELATED HOSPITALIZATION, THIS RIGHT VENTRICULAR LEAD WAS OBSERVED TO HAVE LOSS OF CAPTURE. FURTHER INTERROGATION WAS PERFORMED. ALTHOUGH CONDUCTION OF ATRIAL DEFLECTION TO THE VENTRICLE WAS OBSERVED, INTRINSIC QRS OF 50BPM WAS OBSERVED AND A WENCKEBACH SECOND-DEGREE ATRIOVENTRICULAR BLOCK WAS OBSERVED WITH ATRIAL PACING OF 70PPM. THE PATIENT WAS ASYMPTOMATIC. MEASUREMENTS IN BIPOLAR REVEALED A HIGH OUT OF RANGE IMPEDANCE MEASUREMENT. IN ADDITION, THE LEAD WAS NOT PACING OR SENSING APPROPRIATELY. UNIPOLAR MEASUREMENTS WERE NOT OBTAINED. A REVIEW OF THE DATA DETERMINED HIGH MEASUREMENTS APPROXIMATELY FIVE MONTHS EARLIER AND BEEN VARIABLE SINCE THEN. AN X-RAY DID NOT REVEAL ANY ISSUES. THE DEVICE WAS PROGRAMMED TO AAI/50 PPM. THE FOLLOWING DAY, A LEAD REVISION WAS PERFORMED. PRIOR TO LOOSENING THE SET SCREWS, IT WAS VERIFIED THE CONNECTION HAD BEEN SECURED. MEASUREMENTS WITH THE PACING SYSTEM ANALYZER CONFIRMED THE OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD FRACTURE WAS SUSPECTED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. POST PROCEDURE, ACCEPTABLE MEASUREMENTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382947 THINLINE II IMPLANTABLE LEAD LWS CPI - DEL CARIBE 430-35S-52

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R MISMATCH| (B)(4)| (B)(4)