BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3891886 · Received June 10, 2014

    Report

    Report Number
    1627487-2014-21376
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ST. JUDE MED - 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 MED 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 MED HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR. REPORT: 1627487-2014-21377. REFERENCE MFR. REPORT: 1627487-2014-21378. PER THE MFR'S RECORDS, THE PT HAS THREE 3186 LEADS, HOWEVER, ONE LEAD WAS EXPLANTED PREVIOUSLY (REFERENCE MFR. REPORT: 1627487-2013-19214). THE LOT NUMBER OF THE EXPLANTED LEAD IS UNK. IT WAS REPORTED THE PT EXPERIENCED UNWANTED RIBS/ABDOMEN STIMULATION. REPROGRAMMING WAS UNSUCCESSFUL. X-RAYS WERE TAKEN AND SURGICAL INTERVENTION MAY TAKE PLACE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341047 OCTRODE SCS LEAD GZB ST. JUDE MED - NEUROMODULATION 3186 3813075

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1192| IMPLANT DATE:| SCS ANCHOR, MODEL 1192| IMPLANT DATE: