BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2993945 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-02319
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 12, 2013
    Report Date
    February 8, 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 3. REFERENCE MFR. REPORTS: 1627487-2013-02318 AND 1627487-2013-02320. THE PT REC'D THREE LEADS IN HER THORACIC REGION AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT COMPLAINED OF ABDOMINAL STIMULATION AND REPROGRAMMING COULD NO LONGER RESOLVE THE ISSUE. THE PT ALSO REPORTED STIMULATION IN HER ARMS AND HANDS, AND SHE STATED STIMULATION WAS TOO STRONG IN HER FEET WHEN SHE TURNED UP STIMULATION IN HER LOWER BACK AND THIGHS. IT WAS REPORTED ONE OF THE LEADS HAD MIGRATED. THE PHYSICIAN PLANS TO REVISE THE PT'S LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89251 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3777648

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| SCS EXTENSION: MODEL 3341| SCS IGP: MODEL 3788