BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2230599 · Received August 12, 2011

    Report

    Report Number
    1627487-2011-02926
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    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 INFO 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-02935. THE PT RECEIVED HER SYSTEM ON (B)(6) 2010, WHICH LEADS WERE PLACED SUPRA-ORBITAL (OFF-LABEL). IT WAS REPORTED THAT THE PT WAS EXPERIENCING PAIN AT THE INCISION AREA. THE LEADS WERE EXPLANTED AND REPLACED IN A NEW LOCATION. THE EXPLANTED LEADS WERE RETURNED TO THE MFR FOR ANALYSIS. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3161489

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT:| IMPLANT:| SCS LEAD: MODEL: 3186