BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2952065 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00384
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 28, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 2012 (B)(6); 6947 IMPLANTABLE TACHY LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS PRODUCING DIAPHRAGMATIC STIMULATION. THE DEVICE WAS REPROGRAMMED AND THE LEAD ELE CTRONICALLY ABANDONED UNTIL THE NEXT FOLLOW-UP. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). IT WAS FURTHER REPORTED THAT THE LEAD WAS REPOSITIONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS PRODUCING DIAPHRAGMATIC STIMULATION. THE DEVICE WAS REPROGRAMMED AND THE LEAD ELECTRONICALLY ABANDONED UNTIL THE NEXT FOLLOW-UP. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY (SLS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57053 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention 4076 IMPLANTABLE PACING LEAD