BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 2051323 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01344
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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) 2007. IT WAS REPORTED THAT THE PHYSICIAN EXPLANTED AND REPLACED THE PT'S IPG ON (B)(6) 2011 DUE TO BATTERY DEPLETION. IT WAS REPORTED THAT THE PT HAD NOT USED THE IPG FOR SEVERAL YEARS SINCE IT WAS DEPLETED. NO FURTHER PT COMPLICATIONS 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 DIVISION 3608 84077

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention