BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1896420 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05030
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 25, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOW IMPEDANCES MEASURING BETWEEN 150 TO 199 OHMS IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. NOISE WAS ALSO NOTED ON STORED ELECTROGRAMS. THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THE LEAD CONTINUES TO EXHIBIT LOW IMPEDANCE AND INTERMITTENT NOISE. THE LEAD ALSO EXHIBITED HIGH THRESHOLDS AND FLUOROSCOPY REVEALED THAT THE LEAD EXHIBITED CLAVICULAR CRUSH. THE LEAD WAS CAPPED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention (B)(4)