BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2843408 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-12509
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    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

    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 4. REFERENCE MFR REPORT #1627487-2012-12508, 12510, 12511. IT WAS REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO INFECTION THAT ENCOMPASSED THE ENTIRE IMPLANT. FURTHER INFORMATION IS UNAVAILABLE AT THIS TIME. NOTE THE PATIENT HAS THREE LEADS, OF TWO DIFFERENT MODELS, IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3558616

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS ANCHOR, MODEL 1192| IMPLANT DATE: