BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2172580 · Received July 20, 2011

    Report

    Report Number
    1627487-2011-06010
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 # 1627487-2011-06009. THE PATIENT RECEIVED AN SCS SYSTEM ON (B)(6) 2007 INCLUDING TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION AND EFFORTS TO RECAPTURE EFFECTIVE THERAPY VIA REPROGRAMMING PROVED UNSUCCESSFUL. A SUBSEQUENT X-RAY REVEALED A LEAD FRACTURE. THE PATIENT DENIES EXPERIENCING ANY TRAUMATIC EVENT WHICH MAY HAVE ATTRIBUTED TO THIS MATTER, BUT HE DOES EXERCISE FREQUENTLY. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 57640

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3716