BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2973573 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-02242
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 2. REFERENCE MFR REPORT: 1627487-2013-02241. THE PATIENT RECEIVED THREE PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS) IN HER OCCIPITAL REGION FOR MIGRAINES (OFF-LABEL). IT WAS REPORTED, THE PATIENT REQUESTED HIS SYSTEM BE EXPLANTED DUE TO LACK OF EFFICACY. IT WAS REPORTED, THE PATIENT HAD BEEN REPROGRAMMED AND FELT STIMULATION IN THE DESIRED LOCATION; HOWEVER, HE FELT HE WAS NOT GETTING SUFFICIENT BENEFIT FROM HIS SYSTEM. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72537 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156MI 97184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention IMPLANT DATE:| SCS EXTENSION, MODEL 3386MI (2)| IMPLANT DATE:| SCS IPG, MODEL 3716