BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3993544 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09268
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 MEDICAL PRODUCTS: 5076-58 LEAD, (B)(6) 2013; 5076-52 LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR A SYSTEM UPGRADE. PER THE PHYSICIAN THE PATIENT HAD A HISTORY OF PHRENIC STIMULATION WITH THE CHRONIC LEFT VENTRICULAR (LV) LEAD. AT THE TIME OF THE DEVICE UPGRADE IT WAS NOTED DURING THE PRE-IMPLANT CHECK THAT THE LV LEAD WAS PROGRAMMED OFF. AFTER POSITIONING OF A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ELECTRODE, THE PACING CONFIGURATION LVRING TO RVCOIL WAS ATTEMPTED WITH PHYSICIAN REPORTED NO PHRENIC AT 10 V (ALL OTHER CONFIGURATIONS RESULTED IN PHRENIC STIM). GIVEN THE NEW CONFIGURATION FOR PACING WITHOUT PHRENIC, THE DECISION WAS MADE TO NOT REVISE THE LV LEAD. HOWEVER, POST OPERATIVELY, THE PATIENT BEGAN COMPLAINING OF PHRENIC STIMULATION. THIS COULD NOT BE PROGRAMMED AROUND GIVEN THAT THE PATIENT WAS STILL FEELING PHRENIC STIM AT LV THRESHOLD. THE PHYSICIAN MADE THE DECISION TO PROGRAM THE LV LEAD OFF AND INCREASE THE PATIENT'S AV DELAYS TO PROMOTE INTRINSIC CONDUCTION. THE LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468637 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R C2TR01 IPG