BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3864770 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07507
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: C4TR01 IPG, IMPLANTED: (B)(6) 2013; 407645 LEAD, IMPLANTED: (B)(6) 2013; 3778-60 X 2 PAIN STIM LEAD, IMPLANTED: (B)(6) 2007; 37742 NEURO PROGRAMMER, IMPLANTED: (B)(6) 2007; 37711 PAIN STIM IPG, IMPLANTED: (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. ELECTRICAL TEST RESULTS WERE PASSED, VISUALLY AND ELECTRICALLY WITH DESTRUCTIVE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS WITH INTERMITTENT CAPTURE. ALSO, THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED UNEXPECTED LONGEVITY. THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338457 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 407658 LEAD