BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISXP

    MDR report key: 3161467 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02790
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORTS: 1627487-2013-02791 AND 1627487-2013-02792. IT WAS REPORTED THE PATIENT RECEIVED A LOW BATTERY WARNING MESSAGE WHEN HE TRIED TURNING THE SYSTEM ON. HE ALSO COMPLAINED OF OCCASIONAL PAIN AT THE IPG SITE. IT WAS REPORTED THE PATIENT HAD NOT USED HIS SYSTEM IN OVER 2 YEARS DUE TO INADEQUATE STIMULATION COVERAGE, AND HE IS CONSIDERING HAVING THE SYSTEM EXPLANTED. THE PATIENT PLANNED TO MEET WITH HIS PHYSICIAN AND SJM REPRESENTATIVE AT A LATER DATE REGARDING THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248931 GENESISXP SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3644 38045A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention