BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 19035785 · Received April 3, 2024

    Report

    Report Number
    1627487-2024-07638
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 17, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9242372. COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN20450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9242372.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE SCS SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07637. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545979 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9242372 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other DRG LEADX2