BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 15657754 · Received October 24, 2022

    Report

    Report Number
    3006705815-2022-17583
    Event Type
    Injury
    Date Received
    October 24, 2022
    Date of Event
    October 7, 2022
    Report Date
    December 15, 2022
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE OF EVENT IS UNKNOWN. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7110447.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2022 DURING WHICH THE PATIENT'S ENTIRE SCS SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD IS LIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821526 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000082304 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other SCS ANCHOR (X2).| SCS IPG.| SCS LEAD.