BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2844486 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-02692
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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: 1627487-2012-02693. IT WAS REPORTED, THE PT'S PERCUTANEOUS LEADS HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS WITH A PADDLE LEAD. FOLLOW-UP IDENTIFIED THE SJM REPRESENTATIVE WAS UNABLE TO PROGRAM THE PT AT HER APPOINTMENT SINCE SHE HAD NOT CHARGED HER IPG. THE PT WILL BE REPROGRAMMED AT A LATER DATE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3193922

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788