BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 20645627 · Received November 8, 2024

    Report

    Report Number
    1627487-2024-11917
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    October 17, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8042800.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE STIMULATION. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904411 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8042800 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG.| DRG LEAD.