BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2921633 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-02078
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 3. REF MFR REPORTS: 1627487-2012-02832 AND 1627487-2013-02079.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13995 DUAL EXTENSION SCS EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3346 3161544

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS LEAD, MODEL 3149 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD, MODEL 3166 (2)| IMPLANT DATE:| SCS LEAD, MODEL 3169 (2)| IMPLANT DATE:| SCS IPG, MODEL 3716 (2)