BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 4157944 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-10495
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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: A 5076-45 LEAD IMPLANTED: (B)(6) 2008. A 6947-58 LEAD, IMPLANTED (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED FEELING THE DEVICE PALPITATING, FEELING A ¿HIC¿. THE PATIENT STATED THAT SOME PROGRAMMING CHANGES HAD BEEN MADE BUT THE FEELING HAD STARTED AGAIN. FOLLOW UP WAS CONDUCTED AND INDICATED THAT THE PATIENT HAD BEEN EXPERIENCING LEFT VENTRICULAR (LV) LEAD STIMULATION. THE PATIENT WAS SEEN TWICE AFTER THE DATE OF THE REPORT. PROGRAMMING CHANGES WERE DONE AT BOTH OFFICE VISITS TO ALLEVIATE THE STIMULATION. THE LV 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
    642053 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention DTBA1D1 ICD