BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1854844 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09303
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S003
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 RIGHT VENTRICLE (RV) AND LEFT VENTRICLE (LV) LEADS HAD HIGH IMPEDANCE AND APPARENT FRACTURE. THE LV LEAD HAD NO CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED. THE LV LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.IT WAS REPORTED THAT THE RIGHT VENTRICLE AND LEFT VENTRICLE LEADS HAD HIGH IMPEDANCE AND APPARENT FRACTURE. THE LEFT VENTRICULAR LEAD HAD NO CAPTURE. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. THE LEFT VENTRICULAR LEAD WAS CAPPED. 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 66 YR Other| R 8042 IMPLANTABLE PULSE GENERATOR