BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3862543 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06847
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PRODUCT: 694265 LEAD, IMPLANTED: (B)(6) 1999.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH POCKET STIMULATION. AT THE TIME, THE PATIENT WAS CONTINUED TO BE MONITORED. THE POCKET STIMULATION WAS STILL OCCURRING, SO THE PATIENT PRESENTED TO THE CLINIC WHERE THE CLINICIAN INCREASED THE LEFT VENTRICULAR (LV) OUTPUT AND THE STIMULATION WAS VISUALIZED. THE LV LEAD WAS REPROGRAMMED AND 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
    339942 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention DTBA1D1 ICD