BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 110CM LENGTH

    MDR report key: 2003856 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-00253
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 REPORT #S 1627487-2011-00252 AND 1627487-2011-00254. THE PATIENT RECEIVED AN SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND TWO ANCHORS. IT WAS REPORTED THAT THE PATIENT'S SCS SYSTEM WAS EXPLANTED ON (B)(6) 2011 DUE TO LEAD EROSION AND A POSSIBLE SUBCUTANEOUS INFECTION AT THE LEAD SITE. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS ARE UNKNOWN. ORAL ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 110CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3181 2800215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention