BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2042070 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-01330
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 REPLACED AND RELEASED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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

    THE PT RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT COMPLAINED OF ABDOMINAL PAIN WHEN THE STIMULATION WAS ON OR OFF. THE PHYSICIAN PLANNED TO REVISE THE LEAD LOCATION, BUT INTRAOPERATIVE, HE DECIDED TO EXPLANT AND REPLACE THE LEAD WITH A DIFFERENT MODEL SURGICAL LEAD. THE PT REPORTED EFFECTIVE STIMULATION POSTOPERATIVE. THE PHYSICIAN STATED THAT THE ABDOMINAL PAIN WAS LIKELY RELATED TO THE ORIGINAL PLACEMENT OF THE LEAD TOO FAR OFF MIDLINE. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3179692

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention