BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2850125 · Received November 27, 2012

    Report

    Report Number
    1627487-2012-11715
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 31, 2012
    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 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

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED, THE PATIENT HAD LOW IMPEDANCES ON MULTIPLE CONTACTS ON HER LEADS. IN ADDITION, THERE WAS ONE HIGH IMPEDANCE CONTACT. THE PHYSICIAN OPTED TO PERFORM SURGICAL INTERVENTION. DURING THE PROCEDURE ON (B)(6) 2012, THE LEADS WERE RECONNECTED TO THE IPG, AND THE SYSTEM TESTED WITHIN NORMAL LIMITS. THE PHYSICIAN DID NOT REMOVE ANY DEVICES; THE INCISION WAS CLOSED AND THE PATIENT RECEIVED STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3710356

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788