BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2033525 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-01308
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. THE PRODUCT WAS REWORKED AND RELEASED 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 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 3 OF 3. REFERENCE MANUFACTURER REPORT: 1627487-2011-01306 AND 1627487-2011-01307. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED BECAUSE HE HAD DEVELOPED AN INFECTION OF HIS LEAD INCISION SITES. THE PATIENT STATED THAT HE COULD NOT RECALL THE EXPLANT DATE, BUT IT HAD OCCURRED SOMETIME IN (B)(6). CULTURE RESULTS SHOWED A (B)(6). THE PATIENT STATED THAT THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT 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 3161537

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R