BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950139 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-21433
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-21432. THE PT RECEIVED TWO SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED COMMUNICATION COULD NOT BE ESTABLISHED BETWEEN THE PT'S IPG AND MULTIPLE EXTERNAL DEVICES. THE PT HAD NOT USED/CHARGED THE SCS SYS FOR APPROXIMATELY A YEAR. FOLLOW-UP IDENTIFIED THE PT'S IPG WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, DIAGNOSTICS INDICATED INVALID IMPEDANCES ON BOTH LEADS. VISUAL INSPECTION REVEALED BOTH LEADS APPEARED TO BE FRACTURED AT THE ANCHOR SITES. AS A RESULT, THE LEADS WERE EXPLANTED AND REPLACED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376801 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3523753

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)