BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 15443436 · Received September 18, 2022

    Report

    Report Number
    3006705815-2022-16880
    Event Type
    Injury
    Date Received
    September 18, 2022
    Date of Event
    August 30, 2022
    Report Date
    October 6, 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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16881. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPY DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN ON (B)(6) 2022 WHERE BOTH LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604186 OCTRODE LEAD KIT, 60CM LENGTH PERCUTANEOUS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3186 A000102569 05415067017246

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SCS IPG