BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS DUAL 4 CHANNEL IPG

    MDR report key: 2230418 · Received August 15, 2011

    Report

    Report Number
    1627487-2011-07072
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO LACK OF EFFICACY. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS DUAL 4 CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3643 117454

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SCS LEAD: MODEL 3151 (S)| IMPLANT DATE: