BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2212643 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-05025
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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 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#: 1627487-2011-05024. THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 WITH TWO PERCUTANEOUS LEADS. IT WAS REPORTED THAT SHE ONLY FEELS A LITTLE STIMULATION IN HER LEFT LEG. SHE HAS BEEN REPROGRAMMED MULTIPLE TIMES. AN X-RAY SHOWED BOTH LEADS MIGRATED TO THE RIGHT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3203868

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other