BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 18591764 · Received January 26, 2024

    Report

    Report Number
    3006705815-2024-00677
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    January 5, 2024
    Report Date
    February 15, 2024
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017246
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ESTIMATED. THE ALLEGATION IS AGAINST [1] OF [2] [LEAD]. HOWEVER, IT IS UNKNOWN WHICH [LEAD(S)], THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 318HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/D11.JSF#6, UDI: (B)(4), SERIAL: (B)(6), BATCH: A000107794.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-01229. ADDITIONAL INFORMATION WAS RECEIVED STATING IT WAS INITIALLY THOUGHT ONLY LEAD HAD MIGRATED AND HAD IMPEDANCES BUT UPON FURTHER INVESTIGATIONS ONE LEAD MIGRATED AND ONE LEAD HAD HIGH IMPEDANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEFT LEAD HAD MIGRATED, AND SYSTEM DIAGNOSTICS RECORDED HIGH IMPEDANCES ALSO ON THE LEAD. AS A RESULT, THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE WHERE THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. THE ALLEGATION IS AGAINST [1] OF [2] [LEAD]; HOWEVER, IT IS UNKNOWN WHICH [LEAD(S)], THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: A000107794.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534378 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000107793 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS ANCHORS (X2)| SCS IPG| SCS LEAD