BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1924520 · Received December 7, 2010

    Report

    Report Number
    1627487-2010-03458
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 3 OF 3. REFERENCE MFR. REPORT # 1627487-2010-03456 AND 1627487-2010-03457. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008 CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS. THE LEADS WERE IMPLANTED IN THE OCCIPITAL AREA (OFF-LABEL INDICATION). IT WAS REPORTED THAT THE PT'S IPG AND LEADS WERE REPLACED ON (B)(6) 2010, DUE TO LEAD FRACTURE. THE PT REPORTEDLY EXPERIENCED A GRADUAL LOSS OF STIMULATION. PREVIOUS DIAGNOSTIC TESTS ON THE LEAD(S) REVEALED INVALID IMPEDANCE READINGS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL -NEUROMODULATION DIVISION 3189 97325

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention