BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II

    MDR report key: 3053606 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05528
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2012
    Report Date
    April 24, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN RV LEAD REVISION WITH REPORTS OF DIZZINESS AND NOTED RV LOSS OF CAPTURE. DURING THE PROCEDURE THE PHYSICIAN OBSERVED THAT THE IMPLANTED POSITION OF THE LEAD WAS SUGGESTIVE OF CLAVICLE ENTRAPMENT, RESULTING IN LEAD PHYSICAL DAMAGES. THE LEAD SUSTAINED FURTHER DAMAGES DURING THE EXTRACTION PROCEDURE AND THUS WAS DISCARDED AT THE MEDICAL FACILITY. ANOTHER BOSTON SCIENTIFIC RV LEAD WAS SUCCESSFULLY IMPLANTED. IN THE ABSENCE OF A RETURNED PRODUCT, THE INVESTIGATION OF THIS CASE IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ON-OFFICE INTERROGATION, PACING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS, WAS OBSERVED. THE DEVICE'S LOGBOOK REVIEW WAS INDICATIVE OF EMI/NOISE; HOWEVER, THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS UNABLE TO REPRODUCE THE SAME EFFECT DURING THE IN-OFFICE CLINICAL VISIT. THE SYSTEM WAS REPROGRAMMED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. TO DATE, THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155868 THINLINE II IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-35S-52

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 1270| 1291| (B)(4)| (B)(4)