BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012472 · Received March 15, 2013

    Report

    Report Number
    1627487-2013-05367
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    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 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#: 1627487-2013-05368. IT WAS REPORTED THE PT HAS FALLEN ON SEVERAL OCCASIONS AND IS NO LONGER RECEIVING EFFECTIVE COVERAGE FROM BOTH LEADS. AN IMPEDANCE CHECK REVEALED INVALID CONTACTS ON ONE OF THE LEADS. X-RAYS WERE TAKEN AND NO ANOMALIES WERE FOUND. REPROGRAMMING WAS UNSUCCESSFUL. AS A RESULT, THE PT WILL UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110464 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3371397

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention IMPLANT:| IMPLANT:| SCS ANCHORS: MODEL 1192 (X2)| SCS IPG: MODEL 3788