BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2201748 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11185
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD FRACTURED AND THAT THERE WAS HIGH IMPEDANCE, OVERSENSING, AND INCREASED THRESHOLDS. CAPTURE COULD NOT BE MAINTAINED, AND THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. IT WAS NOTED ON FLUOROSCOPY THAT THE LEAD PIN MIGHT BE PULLED BACK INTO THE CONNECTOR BLOCK. HOWEVER, AFTER RESEATING THE PIN THE HIGH IMPEDANCE, NO CAPTURE, AND STIMULATION CONTINUED. THE LEAD WAS CAPPED AND REPLACED, AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD