BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3110833 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02606
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 2 OF 3. REFERENCE MFR. REPORTS: 1627487-2013-02605 AND 1627487-2013-02607. THE PT HAD FOUR LEADS FROM 2 SEPARATE LOTS. IT WAS REPORTED, THE PT'S IPG HAD ERODED THROUGH THE SKIN AND THE PT COMPLAINED OF INEFFECTIVE STIMULATION COVERAGE. CONSEQUENTLY, THE PT'S SYSTEM WAS REMOVED DUE TO THE ISSUES. THE PT'S WIFE COULD NOT RECALL THE EXPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205031 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 2781312

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCS EXTENSION: MODEL 3342| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENTION: MODEL 3341