BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2153136 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-00870
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00871. THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT HAS BEEN REPROGRAMMED ON MULTIPLE OCCASIONS DUE TO INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. AN X-RAY WAS TAKEN FOR FURTHER INTERROGATION WHICH REVEALED A SLIGHT MIGRATION OF THE PATIENT'S LEFT LEAD. SURGICAL INTERVENTION WILL BE UNDERTAKEN AT A LATER DATE TO ADDRESS THESE ISSUES.

    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 3185461

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED: