BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 6985931 · Received October 27, 2017

    Report

    Report Number
    3006705815-2017-01504
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    October 10, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INADVERTENTLY REPORTED, IN THE INITIAL REPORT THAT THE LEAD WAS REPOSITIONED. THE INFORMATION IS CORRECTED IN THE ADDITIONAL REPORT. IT WAS REPORTED THAT DURING THE LEAD REPLACEMENT PROCEDURE THE PHYSICIAN EXPLANTED ONE OF THE TWO LEADS BUT THE PHYSICIAN WAS UNABLE TO PLACE THE SECOND LEAD IN THE TARGETED AREA AND THE PATIENT EXPERIENCED UNDESIRABLE STIMULATION. AS A RESULT, ONLY ONE LEAD IS LEFT IMPLANTED. REFERENCE MFR. REPORT # 3006705815-2017-01526.

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. 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 # 3006705815-2017-01505.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFT REPORT #3006705815-2017-01505. ADDITIONAL INFORMATION RECEIVED THAT PATIENT IS NOT GETTING GOOD COVERAGE. PHYSICIAN HAS DECIDED TO PUT A COMPETITOR DEVICE.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT # 3006705815-2017-01505. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRABLE STIMULATION. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2017 WHEREIN ONE OF THE TWO LEADS WAS REPOSITIONED AND OTHER LEAD LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762400 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000027538

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other