BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2812495 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15940
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 POST IMPLANT, THE LEFT VENTRICULAR LEAD HAD A MINOR CHANGE IN POSITION THAT RESULTED IN DIAPHRAGM STIMULATION. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE (B)(4) STUDY. 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 ABILITY PLUS IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4296

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) TISSUE VALVE| 5076 X2 IMPLANTABLE PACING LEADS