BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II

    MDR report key: 2050597 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03263
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION REVEALED A LEAD SAFETY SWITCH HAD OCCURRED. AS IMPEDANCE MEASUREMENTS HAD RECENTLY INCREASED, IT WAS THOUGHT THERE MAY BE AN INTERMITTENT LEAD FRACTURE. DAILY MEASUREMENTS AND ELECTROGRAMS DID NOT REVEAL ANY ISSUES. THIS LEAD WILL BE FURTHER MONITORED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 430-35S-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Other