BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE

    MDR report key: 2971540 · Received February 4, 2013

    Report

    Report Number
    1627487-2013-03178
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 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: 1627487-2013-03179. THE PATIENT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IN UNABLE TO INCREASE THE AMPLITUDE OF SYSTEM STIMULATION FOR ONE OF HER SCS LEADS. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47217 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3735192

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS ANCHOR, MODEL 1192 (3)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS EXTENSION: MODEL 3341