BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1921435 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12522
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    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
    OH, 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 PATIENT ALERT TRIGGERED DUE TO HIGH IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS DISLODGEMENT ON THE LEFT VENTRICULAR LEAD. THE LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 52 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB