BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP CONVENTIONAL IPG

    MDR report key: 1990667 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01111
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: THE IPG WAS RETURNED WITH INCOMPLETE LEAD SEGMENTS IN THE HEADER, AND CONSIDERABLE FORCE WAS REQUIRED TO EXTRACT THE LEAD SEGMENTS FROM THE HEADER PORTS. THE IPG PASSED THE LEAD PULL-OUT TEST DURING FUNCTIONAL TESTING; NO LEAD PULL-OUT WAS OBSERVED WHEN THE LEADS WERE PROPERLY INSERTED IN THE HEADER PORTS. 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 HER SCS SYSTEM, INCLUDING AN IPG AND PERCUTANEOUS LEADS IMPLANTED IN THE OCCIPITAL AREA (CLINICAL STUDY FOR MIGRAINES), ON (B)(6) 2008. IT WAS REPORTED THAT THE PT FELL IN (B)(6) 2010, AND SHE CONSEQUENTLY LOST STIMULATION. AN X-RAY REVEALED THAT ONE OF THE LEADS HAD PULLED OUT OF THE IPG HEADER. THE IPG WAS EXPLANTED ON (B)(6) 2011 AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISXP CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3644MI 97946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention