BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2890812 · Received December 21, 2012

    Report

    Report Number
    1627487-2012-06993
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    August 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    THE PT HAD TWO LEADS (FROM THE SAME LOT) FOR OFF-LABEL USE. IT WAS REPORTED, THE PT HAD LOST COVERAGE. X-RAYS REVEALED BOTH LEADS HAD MIGRATED. DURING SURGICAL INTERVENTION, THE DOCTOR DAMAGED THE LEADS. AS A RESULT, BOTH LEADS WERE EXPLANTED AND REPLACED. COVERAGE WAS REGAINED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3593611

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788