BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4833907 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06896
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 10, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE A PATIENT CURRENTLY ENROLLED IN THE (B)(6) STUDY SUFFERED A PERICARDIAL EFFUSION DURING A DIFFICULT LEFT VENTRICULAR (LV) LEAD PLACEMENT WHICH DISLODGED THE ALREADY PLACED RIGHT VENTRICULAR (RV) LEAD. UPON REMOVAL OF THE RV LEAD TO REIMPLANT, THE PHYSICIAN NOTICED THE INNER WIRE WAS EXPOSED THROUGH THE INSULATION. THE LEAD MAY HAVE BEEN CUT WHILE TRYING TO CANNULATE THE CORONARY SINUS. BOTH THE LV LEAD AND RV LEAD WERE REMOVED AND NEW LEADS WERE PLACED WITHOUT INCIDENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378057 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| L| R 6935M62 , LEAD