BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2832022 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-11661
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 17, 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 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 2 OF 3. REFERENCE MFR REPORT: 1627487-2012-11660, 11662. IT WAS REPORTED THE PT FELT AS IF HER IPG HAD PRESSURE OR AS IF WAS BEING PUSHED UPON. THE SJM REP MET WITH THE PT AND PHYSICIAN AND DETERMINED THE PT STILL HAD IMPLANT PAIN IN WHICH SHE FELT SPASMS AROUND THE IPG SITE. THE PT REPORTED IT WAS UNCOMFORTABLE TO SITE. THE PT REPORTED IT WAS UNCOMFORTABLE TO SIT, AND THE PAIN WAS PRESENT WHETHER THE SCS SYSTEM WAS TURNED ON OR OFF. THE PT WAS PRESCRIBED A MUSCLE RELAXANT, AND IT WAS RECOMMENDED TO TURN THE SYSTEM OFF FOR A MONTH. THE PT MET WITH THE PHYSICIAN AGAIN, DUE TO NAUSEA, CRAMPS, WEAKNESS, AND CHILLS. THE PHYSICIAN REVIEWED THE SITUATION, AND X-RAYS WERE TAKEN. IT WAS REPORTED ONE OF THE LEADS HAD MIGRATED. THE PHYSICIAN DID NOT SEE OTHER ANOMALIES. IT WAS REPORTED THE SYSTEM WAS FUNCTIONING PROPERLY AND PROVIDING RELIEF. FURTHER F/U FOUND THE PHYSICIAN EXPLANTED THE SCS SYSTEM. IT WAS REPORTED THE PHYSICIAN DID NOT FEEL THE PT WAS A GOOD CANDIDATE FOR THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3700985

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT: