BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY

    MDR report key: 3863352 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06679
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE DISTAL CONDUCTOR WAS OBSTRUCTED BY A STYLET /GUIDEWIRE FRAGMENT. THERE WAS FOREIGN MATERIAL ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE DISTAL CONDUCTOR OF THE LEAD WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE FRAGMENT STUCK IN THE LUMEN. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION. VISUAL INSPECTION FOUND CONDUCTORS DISTORTED AND FOREIGN MATERIAL VISIBLE INSIDE LUMEN. PERFORMED DESTRUCTIVE ANALYSIS, THERE WAS A COMPETITOR GUIDEWIRE FRAGMENT INSIDE LUMEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE FOR A SYSTEM UPGRADE, HIGH THRESHOLDS WERE INDICATED ON THE ATTEMPTED LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REMOVED 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
    340891 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 1688T ST JUDE LEAD