BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2203425 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11866
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    OK, 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 IN SEGMENTS AND ANALYZED. PRIMARY ANALYSIS REVEALED NO ANOMALIES. HOWEVER, THE DISTAL CONDUCTOR WAS DISTORTED. THE INNER AND OUTER TUBING WAS KINKED/BUCKLED. THE OUTER TUBING OVERLAY WAS MELTED AND THE OUTER INSULATION WAS TORN. THE OUTER INSULATION HAD A COSMETIC CUT AND COSMETIC DEPRESSION. ALL INSULATORS WERE BREACHED CUT. THE LEAD APPEARED STRETCHED. VISUAL ANALYSIS REVEALED THAT THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. THE LV LEAD WAS CAPPED AND REPLACED. THE RV LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LV LEAD HAD POSITIONING DIFFICULTIES DUE TO PATIENT ANATOMY. THE LEAD WAS IMPLANTED AND IS STILL IN USE. 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. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB