BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2952008 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00321
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: (B)(4), IMPLANTABLE TACHY LEAD, - (B)(6) 2012; 5076, IMPLANTABLE PACING LEAD, - (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND NOISE. ADDITIONALLY, THE RV LEAD HAS EXHIBITED A DECREASE IN SENSING R-WAVES SINCE IMPLANT. THE LEAD POLARITY WAS REPROGRAMMED, AND THE LEAD REMAINS IN USE. ADDITIONALLY, THE PATIENT EXPERIENCED INTERMITTENT PHRENIC STIMULATION WHILE LYING ON THE RIGHT SIDE. THE OUTPUT OF THE LEFT VENTRICULAR (LV) LEAD WAS DECREASED, AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55445 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention (B)(4) IMPLANTABLE DEFIBRILLATOR