BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 4162453 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12728
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: D224TRK ICD, IMPLANTED (B)(6) 2013; 37702 PAIN STIM IPG, (B)(6) 2009; 748940 NEURO EXTENSION, (B)(6) 2005; 3998 PAIN STIM LEAD, (B)(6) 2005; 748940 NEURO EXTENSION, (B)(6) 2005; 7435 NEURO PROGRAMMER, (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AS WELL AS HIGH IMPEDANCES IN ALL PACING VECTORS. THE LEAD IMPEDANCE ROSE ABRUPTLY AROUND (B)(6) 2013. . A LEAD FRACTURE IS SUSPECTED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION AS THE LV LEAD THRESHOLD ROSE. THE LV LEAD WAS TURNED OFF AND THE DEVICE PROGRAMMED TO RV PACING ONLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640436 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 6944-65 LEAD