BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 2153388 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-01699
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION, AND THE PT'S PROGRAMMER DISPLAYED A COMMUNICATION ERROR. A NEW PROGRAMMER WAS SENT TO THE PT. F/U ON THE PT FOUND THAT THE NEW PROGRAMMER DID NOT RESOLVE THE ISSUE. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2011. NO FURTHER PT ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3643 2847752

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention SCS LEAD: MODEL: 3156 X 2| IMPLANT: