BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052265 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02458
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02459. THE PATIENT'S PNS SYSTEM WAS IMPLANTED FOR MIGRAINES (OFF-LABEL). THE PATIENT RECEIVED A LETTER REGARDING THE CHARGER SWAP PROGRAM. SHE REPORTED SHE DID NOT WANT TO PARTICIPATE IN THE CHARGER PROGRAM BECAUSE SHE WANTS TO HAVE HER SYSTEM REMOVED. SHE STATED THE SYSTEM HAS NEVER WORKED FOR HER AND ACTUALLY CAUSES DISCOMFORT. SHE ALSO COMPLAINED SHE HAD DIFFICULTY GETTING HER IPG TO TURN OFF. IT WAS REPORTED SHE REFUSED TO BE REPROGRAMMED AND HAD NOT USED OR CHARGED THE SYSTEM FOR SEVERAL MONTHS. FOLLOW-UP INDICATED SURGICAL INTERVENTION WILL TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139702 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3175272

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention IMPLANT DATE:| SCS EXTENSION: MODEL: 3382