BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2813509 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16536
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    June 20, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006/S004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR [LV] LEAD WAS EXPLANTED AND REPLACED. 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 IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4396

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R D334TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947M IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD