BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 16874349 · Received May 5, 2023

    Report

    Report Number
    3006705815-2023-02788
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 14, 2023
    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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. THE ALLEGATION IS AGAINST 1 OF 5 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6042374; COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6002877; COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6042374; COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6002877.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGERY MAY TAKE PLACE IN THE FUTURE. IT IS UNKNOWN WHICH LEAD IS LIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196593 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000032941 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other SCS ANCHOR (X2).| SCS ANCHOR.| SCS IPG.| SCS LEAD (X4).