BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 2041192 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02287
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 23, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. 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 OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED MELTED INSULATION DUE TO ELECTROSURGICAL CAUTERY. THE INSULATION WAS ALSO PUCKERED IN SEVERAL LOCATIONS. THE LEAD WAS ELECTRICALLY CONTINUOUS. ANALYSIS DID NOT REVEAL ANY ANOMALIES WHICH MAY HAVE CONTRIBUTED TO THE MUSCLE STIMULATION AND CANNOT CONFIRM DISLODGEMENT. PLACEMENT OR DISLODGEMENT OF THIS LEAD MAY RESULT IN MUSCLE STIMULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION. THE OUTPUT WAS INCREASED AND THE STIMULATION WAS RESOLVED. TWO DAYS LATER THE LEAD WAS EXPLANTED DUE TO DISLODGEMENT. THE PATIENT HAD DEVELOPED TWIDDLER'S SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R (B)(4)| MISMATCH| (B)(4)| (B)(4)| 4470| 4512| 6943| (B)(4)| (B)(4)| 4086| 1823