BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2251157 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-05128
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 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

    MFR'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LAB TESTING. EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. BOTH LEADS WERE RECEIVED INCOMPLETE AND ONE OF THE LEADS HAD AN INCOMPLETE STIMULATION END. 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 2. REFERENCE MFR. REPORT#: 1627487-2011-015127. THE PT RECEIVED HIS SCS SYSTEM FOR AN OFF-LABEL INDICATION ON (B)(6) 2011 WITH TWO PERCUTANEOUS LEADS (FROM THE SAME LOT). IT WAS REPORTED THAT THE PT'S SYSTEM WAS EXPLANTED DUE TO STAPH INFECTION. THE INFECTION WAS LOCATED NEAR THE SUPRAORBITAL REGION AT THE STIMULATION TIP OF THE LEAD. THE PT'S INFECTION WAS RESOLVED BY USING ORAL ANTIBIOTICS. THE PT IS PLANNING ON RECEIVING A NEW SYSTEM. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3153204

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention