BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C LEAD, 60 CM

    MDR report key: 8622730 · Received May 20, 2019

    Report

    Report Number
    1627487-2019-05752
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05414734406154
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: MEDICAL PRODUCT: MODEL 3662; SCS IPG; THERAPY DATE: UNKNOWN.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2019-05754. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417260 LAMITRODE TRIPOLE 16C LEAD, 60 CM SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 5013625 05414734406154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other