BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192033 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-08238
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-08241. IT WAS REPORTED, THE PT HAD INVALID IMPEDANCES ON ALL HIS LEAD CONTACTS. X-RAY SHOWED A LEAD FRACTURE. THE PT HAD BEEN SCHEDULED FOR AN EXPLANT AND WOULD BE REIMPLANTED WITH COMPETITOR'S PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281051 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 34769778

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other SCS ANCHOR: MODEL: 1192| IMPLANT DATE:| SCS IPG: MODEL: 3788| IMPLANT DATE: