BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3810752 · Received April 28, 2014

    Report

    Report Number
    1627487-2014-05305
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    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 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

    ON (B)(6) 2014, THE PT'S IPG WAS REPOSITIONED (REPORTED UNDER MFR. REPORT#: 1627487-2014-07351, FOLLOW-UP #001). DURING THE PROCEDURE, THE PT'S LEAD WAS FOUND TO HAVE MIGRATED. PRIOR TO THE SURGICAL PROCEDURE THE DEVICE WAS PERFORMING AS INTENDED. REGARDLESS, THE DOCTOR REPOSITIONED THE LEAD. SURGICAL INTERVENTION ADDRESSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254179 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL: NEUROMODULATION 3183 2781313

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other IMPLANT DATE:| SCS IPG: MODEL 3688