BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4151876 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-06296
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 6, 2015
    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 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.

    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 2 OF 3. REFERENCE MFR REPORTS: 1627487-2014-06295 & 1627487-2015-03314.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFER TO MFR REPORT 1627487-2014-06295. THE PT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. INFO PROVIDED BY THE PT'S ATTY INDICATED THAT THE PT ALLEGES THE FOLLOWING ISSUES: THE PT REPORTS HE EXPERIENCED "SEVERE POWER SURGES/SHOCKING," HEAT AND PAIN AT THE IMPLANT SITE (UNK SITE). THE PT'S ENTIRE SCS SYSTEM WAS REMOVED ON (B)(6) 2014. ADDITIONAL INFO IS NEEDED TO CLARIFY THE NATURE OT THE PT'S ISSUES. THE PT'S SCS SYSTEM WAS NOT EVALUATED BY AN SJM REP TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES PRIOR TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623323 OCTRODE SCS LEAD GZB ST JUDE MEDICAL, NEUROMODULATION 3189 3977525

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other SCS ANCHOR: MODEL 1192 (2),| IMPLANT DATE: