BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2060012 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06656
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    October 8, 2010
    Report Date
    May 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY TESTED, THE REPORTED OBSERVATIONS FROM THE FIELD COULD NOT BE CONFIRMED, BUT A TWIST THAT WAS FOUND ON THE LEAD IS CONSISTENT WITH TWIDDLER'S SYNDROME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PATIENT WITH THIS LEFT VENTRICULAR LEAD HAD ELEVATED THRESHOLD MEASUREMENTS. THERE WAS NO SATISFACTORY PROGRAMMING DUE TO DIAPHRAGMATIC STIMULATION. AS A RESULT, THE LEAD WAS PROGRAMMED OFF. A REVISION PROCEDURE WAS DONE AND THIS LEAD WAS FOUND TO HAVE DISLODGED AND WRAPPED AROUND THE RIGHT VENTRICULAR LEAD OVER TEN TIMES, CONSISTENT WITH TWIDDLER'S SYNDROME. A NEW LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R 4592| N119| 0184