BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2040337 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-01244
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY. THE PRODUCT 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 MFR REPORT: 1627487-2011-01245. THE PT REC'D HIS SCS SYSTEM, INCLUDING AN IPG AND PERCUTANEOUS LEAD, ON (B)(6) 2007. THE PT HAD ANOTHER PERCUTANEOUS LEAD IMPLANTED ON (B)(6) 2008. IT WAS REPORTED THAT THE PT LOST STIMULATION. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCES ON ONE OF THE LEADS, AND THE OTHER LEAD EXHIBITED LOW IMPEDANCES ON ALL LEAD CONTACTS. THE PT WAS ALLEGEDLY REPROGRAMMED USING THE LEAD WITH LOW IMPEDANCE READINGS. THE PT STATED HE HAD EFFECTIVE STIMULATION WITH ONLY ONE LEAD, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 65196

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR