BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 10423661 · Received August 18, 2020

    Report

    Report Number
    1627487-2020-30471
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    July 29, 2020
    Report Date
    November 2, 2020
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734406130
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S WEIGHT HAS BEEN OBTAINED AND PROVIDED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    DEVICE 1 OF 2 REFERENCE MFR. REPORT#: 1627487-2020-030472. ADDITIONAL INFORMATION RECEIVED REVEALED BOTH OF THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    DEVICE 1 OF 2; REFERENCE MFR. REPORT#: 1627487-2020-030472. IT WAS REPORTED HIGH IMPEDANCE WAS FOUND ON BOTH OF THE PATIENT'S LEADS. IN TURN, THE PATIENT HAS BEEN UNABLE TO RECEIVE EFFECTIVE THERAPY. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883229 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 4733690 05414734406130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL: 3186| MODEL: 3186