BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3022463 · Received March 20, 2013

    Report

    Report Number
    1627487-2013-05388
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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 3. REFERENCE MFR REPORT #: 1627487-2013-05387. REFERENCE MFR REPORT #: 1627487-2013-05389. THE PT HAD TWO ANCHORS (FROM THE SAME LOT). IT WAS REPORTED THE PT HAD LOST ADEQUATE COVERAGE. X-RAYS REVEALED ONE OF THE PT'S LEADS HAD MIGRATED. DURING SURGICAL INTERVENTION THE ANCHOR ASSOCIATED WITH THE MIGRATED LEAD WAS FOUND TO NOT BE LOCKED IN PLACE. AS A RESULT, BOTH LEADS WERE EXPLANTED AND REPLACED WITH A SINGLE LEAD (DIFFERENT MODEL). THE ANCHOR WAS ALSO EXPLANTED. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115649 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3858973

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192| IMPLANTED:| IMPLANTED: