BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3993249 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09412
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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: D274TRK ICD, IMPLANTED: (B)(6) 2011; 694758 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN THE EXPECTED FOR ITS LONGEVITY. THE DEVICE WAS EXPLANTED AND WAS REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH IMPEDANCE ON THE RV AND SUPERIOR VENA CAVA (SVC) COIL. LOW IMPEDANCE ON THE HIGH VOLTAGE PORTION WAS ALSO NOTED. THE RV LEAD WAS EXPLANTED AND WAS REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE. INITIALLY, REPROGRAMMING WAS PERFORMED ON THE LV LEAD, THEN THE LV LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470898 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 5076-45 LEAD