BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2080519 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-01405
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    November 17, 2010
    Report Date
    March 25, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED VIA LABORATORY TESTING. EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT FUNCTIONALITY OR PRODUCT INTEGRITY. THE PRODUCT WAS REWORKED AND APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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

    REFERENCE MANUFACTURER REPORT: 1627487-2010-03444. THE PT REC'D HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THAT THE PHYSICIAN FELT THE PT'S SURGICAL INCISIONS HAD NOT HEALED COMPLETELY. THE PT WAS TREATED WITH ANTIBIOTICS FOR AN UNDETERMINED PERIOD OF TIME. F/U ON THE PT FOUND THAT THE SURGICAL INCISIONS HAD STILL NOT HEALED PROPERLY. THE PHYSICIAN DECIDED TO EXPLANT THE PT'S IPG AND LEADS ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE 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 3186 2870914

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention