BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3864771 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07499
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 16, 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
    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: PRODUCT ID: A 5076-52 LEAD, IMPLANTED: (B)(6) 2006. PRODUCT ID: 694765 LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT ENDED UP IN THE HOSPITAL BECAUSE THE LEAD WAS NOT IN SYNC WITH THE IMPLANTED DEVICE. FOLLOW UP WITH THE PATIENT¿S CLINIC WAS UNSUCCESSFUL. THE DEVICE AND LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337800 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization D314TRG ICD