BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 2140933 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-00847
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    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 AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS CORRECTED AND THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE REPORTED ISSUE. 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 5. REFERENCE MFR. REPORT #S 1627487-2011-00845, 1627487-2011-00846, 1627487-2011-00848 AND 1627487-2011-00849. THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG, THREE PERCUTANEOUS LEADS FROM THREE DIFFERENT LOTS AND A LEAD EXTENSION. IT WAS REPORTED THAT THE PT CONSTANTLY TAMPERED WITH HER LEAD SITE AND THAT THE AREA APPEARED INFECTED. HER ENTIRE SCS SYSTEM WAS EXPLANTED AS A RESULT. BOTH INTRAVENOUS AND ORAL ANTIBIOTICS WERE ADMINISTERED AS TREATMENT; HOWEVER, A CULTURE WAS NOT TAKEN. FOLLOW-UP ON THIS MATTER FOUND THAT THE REPORTED INFECTION HAS COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 90 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3169 174299

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention