BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2951512 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00120
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE DEFIBRILLATOR LEAD (B)(6) 2010; 5076 IMPLANTABLE PACING LEAD (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE PROXIMAL LEAD CONDUCTOR WAS NOT OBSTRUCTED WITH BLOOD. THE DISTAL LEAD CONDUCTOR WAS NOT OBSTRUCTED WITH BLOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE SHOCKS DUE TO NOISE ON THE PACE SENSE LEG OF THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD HAD ELEVATED SHORT INTERVAL COUNTER (SIC), HIGH THRESHOLD, AN IMPEDANCE SPIKE, AND OVERSENSING. A FRACTURE WAS SUSPECTED ON THE RV PACE SENSE CONDUCTOR. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD CAUSED DIAPHRAGMATIC STIMULATION TO THE PATIENT. REPROGRAMMING THE LEAD COULD NOT BE ACHIEVED, SO THE DEVICE WAS PROGRAMMED TO SINGLE CHAMBER FIXED RATE (VVI 40). DURING THE REVISION PROCEDURE, THE LV LEAD EXPERIENCED A MICRO-DISLODGEMENT. THE LV LEAD ALSO FELL OUT OF THE DEVICE HEADER DUE TO A CONNECTION ISSUE. THE LV LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. IT WAS ALSO REPORTED THAT THOROUGH TESTING DEEMED THERE WAS LATE PRESENTATION OF THE SET-SCREW IN THE DEVICE HEADER. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON (B)(6) 2012 IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER HEARING ALERTS FOR NOISE AND OVERSENSING ON THE RV LEAD. PRIOR TO EXPLANT, INTERROGATION SHOWED HIGH IMPEDANCE, OVERSENSING AND THE LEAD INTEGRITY ALERT HAD TRIGGERED. DURING THE EXTRACTION OF THE RV LEAD, BOTH THE ATRIAL AND LEFT VENTRICULAR LEADS DISLODGED AND WERE REMOVED. THE NEW RV LEAD WAS IMPLANTED. DUE TO THE PROCEDURE BEING DIFFICULT AND LENGTHY, A NEW RIGHT ATRIAL (RA) LEAD AND (LV) LEAD WILL BE IMPLANTED AT A FUTURE DATE. THE RV LEAD WAS REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE BELIEF THAT THE OVERSENSING AND NOISE WAS BEING CAUSED BY A SET SCREW ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56617 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429678

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR