BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2881422 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-14216
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    September 1, 2011
    Report Date
    December 4, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 5. REFERENCE MFR REPORT: 1627487-2012-14215, 14217, 14218, 14219. THE PATIENT WAS IMPLANTED WITH TWO QUATTRODE LEADS ((B)(4)) WITH THE SAME LOT NUMBER. THE PATIENT WAS ALSO IMPLANTED WITH TWO DUAL EXTENSIONS ((B)(4)) WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT'S ENTIRE SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PATIENT DEVELOPED A PIMPLE OVER ONE OF THE PERIPHERAL LEADS. THE PHYSICIAN BROKE THE PIMPLE, AND TOOK A CULTURE WHICH CAME BACK POSITIVE FOR AN INFECTION. THE SYSTEM WAS THEN EXPLANTED TO BE ON THE SAFE SIDE SOMETIME IN (B)(6) 2011 (EXACT DATE UNKNOWN). THE PATIENT HAD A NEW SCS SYSTEM IMPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 2816135

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention