BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLE 16

    MDR report key: 2903162 · Received January 2, 2013

    Report

    Report Number
    1627487-2013-12005
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    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

    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 2. REFERENCE MFR REPORT #1627487-2013-12004. IT WAS REPORTED FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED PAIN AND WEAKNESS IN LEFT LEG. THE PHYSICIAN EXPLANTED THE SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277 TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3504561

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention