BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2010836 · Received March 3, 2011

    Report

    Report Number
    1627487-2011-01186
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE IDENTIFIED NONCONFORMANCE DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED 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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01187. THE PT ((B)(6)) WAS IMPLANTED WITH A SURGICAL LEAD AND TWO EXTENSIONS (FROM THE SAME LOT) FOR A TRIAL SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION, AND THE DEVICES WERE SUBSEQUENTLY EXPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE INFECTION STARTED AT THE EXTENSION AND MOVED UP TO THE LEAD. A CULTURE WAS NOT TAKEN. IT WAS REPORTED THAT THE PT RECEIVED ORAL ANTIBIOTICS AND HAS RECOVERED FROM THE INFECTION. THE PHYSICIAN STATED THAT THE INFECTION WAS NOT PRODUCT RELATED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3228 3161293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention