BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3861327 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07301
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PATIENT HAD A STENOTIC VEIN/SUPERIOR VENA CAVA (SVC). WHEN PLACING THE LEFT VE NTRICULAR (LV) LEAD, LEAD INTERACTION OCCURRED. THE RIGHT VENTRICULAR (RV) LEAD TANGLED AT THE PROXIMAL PORTION OF THE SVC. WHEN THE PHYSICIAN ATTEMPTED TO STRAIGHTEN IT, THE VEIN COLLAPSED AND THE RV LEAD WAS "SHREDDED. THE LEAD WAS NOT USED AND A NEW RV LEAD WAS IMPLANTED. ALSO DURING THE IMPLANT ATTEMPT, THE LV LEAD DISLODGED THREE TIMES. THE LEAD WAS NOT IMPLANTED AND A NEW LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339558 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR 5076-52