BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1990066 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01124
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    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

    EVAL: DEVICE EVAL WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED BY PRODUCT TESTING. EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND PRODUCT WAS REWORKED AND RELEASED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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 2 OF 4. REFERENCE MFR REPORTS: 1627487-2011-01123, 1627487-2011-01125 AND 1627487-2011-01126. THE PT RECEIVED HER SCS SYS, INCLUDING AN IPG, TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), AND TWO LEAD EXTENSIONS (FROM TWO SEPARATE LOTS), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE LEAD INSERTION SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SCS SYS ON (B)(6) 2011. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR ANALYSIS ON (B)(6) 2011. IT WAS REPORTED THAT A CULTURE WAS TAKEN BY THE PHYSICIAN, BUT THE RESULTS ARE UNK. IT WAS REPORTED THAT THE PHYSICIAN DID NOT FEEL THE CAUSE OF THE INFECTION WAS PRODUCT-RELATED. THE PT WAS TREATED WITH BOTH ORAL AND IV ANTIBIOTICS. F/U ON THE PT FOUND THAT SHE IS RECOVERING FROM THE INFECTION AND IS CONSIDERING BEING REIMPLANTED AT A LATER DATE. NO FURTHER ISSUES HAVE BEEN REPORTED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3186 3108612

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention