BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS 8-CHANNEL RECHARGEABLE IPG

    MDR report key: 2181330 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-03318
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 AN SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT COULD DEVELOP EROSION DUE TO HER SIZE AND INDICATED SHE WAS IN PAIN CAUSED BY THE "SYNDROME OF PAIN IN THE CHEST POCKET". THE PT IS WORKING CLOSELY WITH HER PHYSICIAN TO DEFINE THE NEXT COURSE OF ACTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3153739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG, MODEL: 3788| IMPLANT DATE:| SCS LEAD, MODEL: 3244| IMPLANT DATE: