BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 3231021 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-08348
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ST JUDE MEDCIAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 # 1627487-2013-08349. THE PT REC'D TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT EXPERIENCED POWER SURGES AND BATTERY RECHARGING ISSUES. IT WAS STATED THE PT'S DEVICE WAS REPROGRAMMED IN AN ATTEMPT TO RESOLVE BUT NO FURTHER INFO WAS REPORTED. A SEARCH OF THE MFR'S SYS FOUND NO OTHER COMPLAINTS FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321736 OCTRODE SCS LEAD LGW ST JUDE MEDCIAL - NEUROMODULATION 3186 3359094

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: