BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, 30CM

    MDR report key: 19444259 · Received June 1, 2024

    Report

    Report Number
    1627487-2024-09058
    Event Type
    Injury
    Date Received
    June 1, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067017918
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED PATIENT WEIGHT IS UNKNOWN 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. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: EXTENSION, MODEL: 3383, UDI: (B)(4) , SERIAL: NA, BATCH: 5020864.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4: THE LOT NUMBER SHOULD HAVE BEEN 5020864 NOT 50697.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON 3 CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD EXTENSION WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED. NOTE : IT IS UNKNOWN WHICH EXTENSION IS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318546 EXTENSION, 30CM SCS EXTENSION LGW ABBOTT MEDICAL 3383 5020864 05415067017918

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS EXTENSION| SCS IPG| SCS LEAD