BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 1962671 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-02057
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THE IPG WILL BE EXPLANTED DUE TO A LOSS OF STIMULATION AND DISCOMFORT AT THE IPG POCKET. IT IS CURRENTLY UNK IF THE IPG WILL BE RETURNED TO THE MFR FOR POST-EXPLANT ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3608 176081

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention