BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2033516 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-02357
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K000852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 3 OF 5. REFERENCE MANUFACTURER REPORTS: 1627487-2011-02355, 1627487-2011-02356, 1627487-2011-02358 AND 1627487-2011-02359. THE PT REC'D HIS PNS SYSTEM, INCLUDING FOUR PERCUTANEOUS LEADS (OF TWO SEPARATE LOTS), TWO EXTENSIONS AND AN IPG, ON (B)(6) 2011. IT WAS REPORTED THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED DUE TO AN INFECTION. A CULTURE OF THE INFECTED AREA REVEALED THE INFECTION WAS A (B)(6). THE PT WAS TREATED WITH ORAL ANTIBIOTICS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 3158103

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R