BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3962496 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-21472
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    THE PT RECEIVED TWO SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED DURING THE PT'S IPG REPLACEMENT PROCEDURE (REF MFR REPORT#1627487-2014-23414), THE PHYSICIAN NOTICED BOTH OF THE PT'S SCS LEADS WERE FRACTURED. THE LEADS DISPLAYED INVALID IMPEDANCES. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED BOTH THE PT'S LEADS. THE PT HAS EFFECTIVE STIMULATION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409532 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2760248

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT DATE| SCS ANCHOR, MODEL 1192 (2)| SCS IPG, MODEL 3788| IMPLANT DATE