BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17844768 · Received September 29, 2023

    Report

    Report Number
    1627487-2023-04650
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 4, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: KIT IMPLANTABLE SLIM TIP LEAD, 50CM, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8781318.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-04649. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO LEAD MIGRATION. BOTH LEADS HAD MIGRATED. THE ISSUE WAS CONFIRMED VIA X-RAYS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 DURING WHICH THE EXISTING LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288047 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9110731 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other DRG IPG