BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1910930 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03310
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    August 16, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS 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 4. REFERENCE MANUFACTURER REPORTS: 1627487-2010-3308, 1627487-2010-3309 AND 1627487-2010-3311. THE PT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG, THREE PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), AND AN EXTENSION ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN EROSION TO THE INCISION SITE IN HER BACK. CONSEQUENTLY, THE SYSTEM WAS EXPLANTED ON (B)(6) 2010. ALTHOUGH THE PT WAS TREATED WITH ORAL ANTIBIOTICS, CULTURE RESULTS OF THE EROSION SHOWED NO INFECTION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL. FOLLOW UP ON THE PT FOUND THAT THE PT WAS RE-IMPLANTED SEVERAL MONTHS LATER AND RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3166 2850522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention