BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3010516 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-13290
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 20, 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
    OK, 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

    THE PT HAS TWO LEADS FROM THE SAME LOT NUMBER. THE PT REPORTED SHE NO LONGER HAD STIMULATION. SHE STATED HER IPG WAS FULLY CHARGED AND BOTH THE CHARGER AND PROGRAMMER COMMUNICATED WITH THE IPG. THE PT ALSO REPORTED ALL HER PROGRAMS WERE AUTO REDUCING, HOWEVER, NO ERROR CODES WERE DISPLAYED. FOLLOW-UP INFORMATION IDENTIFIED THE PT HAD FALLEN ON THE ICE AND FELT A BUMP ON HER BACK. DURING A SYSTEM DIAGNOSTIC TEST, IT WAS DETERMINED BOTH OF THE PT'S LEADS HAD INVALID IMPEDANCES. X-RAYS IDENTIFIED THE LEADS WERE FRACTURED. THE PT UNDERWENT A PROCEDURE AND BOTH LEADS AND ANCHORS WERE EXPLANTED AND REPLACED. THE PT HAD EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108276 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3203885

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANT DATE:| EXPLANT DATE:| SCS ANCHOR: MODEL: 1192 (2)