BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE ACTIVE FIX DUAL COIL IS-1/DF-1 64CM

    MDR report key: 1704219 · Received May 21, 2010

    Report

    Report Number
    2124215-2010-10288
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    April 27, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED CLARIFICATION FROM THE FIELD THAT THE REPORTED INFECTION WAS NOT RELATED TO THE DEVICE OR LEADS. THE INFECTION DEVELOPED IN THE FOOT REGION AND THERE WAS NO REASONABLE EVIDENCE TO SUGGEST THAT THE DEVICE OR LEAD SYSTEM CAUSED OR CONTRIBUTED TO THIS CLINICAL OBSERVATION. THE DEVICE WAS EXPLANTED AND RETURNED. LABORATORY TESTING DETERMINED THAT THE DEVICE'S OPERATION AND FUNCTIONALITY WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE ACTIVE FIX DUAL COIL IS-1/DF-1 64CM IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other