BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RECEIVER

    MDR report key: 2920090 · Received December 13, 2012

    Report

    Report Number
    1627487-2012-00801
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    July 20, 2007
    Report Date
    March 7, 2008
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    IT WAS REPORTED THE PT'S (B)(6) NEUROSTIMULATOR RECEIVER WAS REPLACED WITH AN IPG IN 2007. NO FUNCTIONAL ISSUES WERE ALLEGED OR SPECIFIED IN THE NOTIFICATION REGARDING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW RECEIVER SCS RECEIVER LGW ST JUDE MEDICAL - NEUROMODULATION 3416 25732A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SCS LEAD: MODEL 3186| IMPLANT DATE: