BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LOCK ANCHOR

    MDR report key: 2092644 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-01494
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 3. REFERENCE MANUFACTURER REPORT: 1627487-2011-01492 AND 1627487-2011-01493.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LOCK ANCHOR SPINAL CORD STIMULATION LEAD ACCESSORY GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 3269451

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788