BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2812972 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16712
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 29, 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
    PA, 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 TO THE MANUFACTURER AND ANALYZED AND NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED) AND THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE 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 PLUS IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4296

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6935M IMPLANTABLE TACHY LEAD| D204TRM IMPLANTABLE PACEMAKER/CARDIO/DEFIB