BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 4162614 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12680
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 5, 2013
    Report Date
    July 22, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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: 5076-52 LEAD (B)(6) 2005; 6947-65 LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS CHECKED, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD AN INTERMITTENTLY HIGH PACING THRESHOLD. THE THRESHOLDS HAD A PROGRESSIVE RISE. IT WAS ALSO NOTED THAT THERE WAS A LIMIT TO HOW HIGH THE OUTPUTS COULD BE SET DUE TO DIAPHRAGMATIC STIMULATION. THE PATIENT WAS PART OF THE PRODUCT SURVEILLANCE REGISTRY STUDY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS CHECKED IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD AN INTERMITTENTLY HIGH PACING THRESHOLD. IT WAS ALSO NOTED THAT WHEN THE DOCTOR TURNS UP THE OUTPUTS THEY GET STIMULATION, SO THE DOCTOR BACK THE OUTPUTS DOWN TO AVOID. THE PATIENT WAS PART OF THE (B)(6) STUDY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS TURNED OFF AFTER THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644362 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention