BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3863386 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06715
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: 5076-52, LEAD, (B)(6) 2005; 6947-58, LEAD, (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS RIGHT BUNDLE BRANCH BLOCK WITH RECURRENT INTRINSIC CONDUCTION. THE LEFT VENTRICULAR (LV) LEAD HAD BEEN TURNED OFF PREVIOUSLY DUE TO THE PATIENT COMPLAINING OF INTERMITTENT DIAPHRAGMATIC STIMULATION. DURING A NORMAL DEVICE CHANGE OUT THE PHYSICIAN DECIDED TO CAP THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341140 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R D224TRK ICD