BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 1910968 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03317
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    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

    EVALUATION METHOD: THE DEVICE HISTORY 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 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

    DEVICE 2 OF 6. REFERENCE MFR REPORTS: 1627487-2010-03316, 1627487-2010-3318, 1627487-2010-03319, 1627487-2010-03320 AND 1627487-2010-03321. THE PT REC'D HER SCS SYSTEM CONSISTING OF AN IPG, FOUR LEADS (FROM THREE SEPARATE LOTS), AND TWO EXTENSIONS (FROM TWO SEPARATE LOTS) ON (B)(6) 2010. IT WAS REPORTED THAT THE CHARGER WAS UNABLE TO CHARGE OR LOCATE THE IPG. HOWEVER, THE REPLACEMENT CHARGER WAS NEVER USED; THE PT DEVELOPED AN INFECTION OF THE IPG POCKET AND EXTENSION SITE, AND THE SYSTEM WAS CONSEQUENTLY EXPLANTED ON (B)(6) 2010. A CULTURE WAS TAKEN ON (B)(6) 2010 AND RESULTS SHOWED (B)(6). THE PT WAS TREATED WITH ORAL ANTIBIOTICS. F/U ON THE PT FOUND THAT SHE IS RECOVERING WELL AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED DEVICES WILL BE RETURNED TO THE MFR FOR EVAL.

    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 3150054

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention