BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1923049 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13207
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    June 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THERE WAS DIAPHRAMATIC STIMULATION AFTER IMPLANT WITH BOTH RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS AT "LOWEST LEVEL WITH CAPTURE." LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. RIGHT VENTRICULAR LEAD WAS REPOSITIONED AND REMAINS IN USE. 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 ABILITY IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R 8042 IMPLANTABLE PULSE GENERATOR