BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3042334 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-04398
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04399. IT WAS REPORTED THE PATIENT WAS HAVING TROUBLE WITH THE SCS SYSTEM. THE SJM REPRESENTATIVE CONTACTED THE PATIENT TO DETERMINE THE ISSUE. IT WAS REPORTED THE PATIENT HAD NOT USED THE STIMULATION BECAUSE IT WAS INEFFECTIVE IN RESOLVING HIS PAIN. IT WAS REPORTED THE PHYSICIAN HAD DISCUSSED SURGICAL INTERVENTION TO PROVIDE A SURGICAL LEAD REPLACEMENT. IT WAS REPORTED THE PATIENT DID NOT WANT FURTHER INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135347 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 176051

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3716| SCS ANCHOR, MODEL 1194 (2)