BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3123595 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-03651
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    April 23, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03652. THE PATIENT REPORTED SHE IS NOT RECEIVING STIMULATION IN HER PAIN PATTERN AS SHE DID DURING HER TRIAL AND IS RECEIVING UNWANTED STIMULATION IN HER LEGS. THE PATIENT ALSO REPORTED HER SCS SYSTEM HAS BEEN REPROGRAMMED MULTIPLE TIMES TO NO AVAIL. ADDITIONALLY, THE PATIENT REPORTED SHE HAS ARTHRITIS AND SCAR TISSUE. THE PATIENT IS TO CONSULT WITH THE PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. FOLLOW-UP IDENTIFIED A SJM REP WAS UNABLE TO RESOLVE THE ISSUE WITH ADD'L REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219661 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3186 3599429

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: