BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3860172 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05560
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO LEADS WERE ATTEMPTED BUT NOT USED DURING THE IMPLANT PROCEDURE DUE TO DISLODGEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337899 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR