BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 20944881 · Received December 16, 2024

    Report

    Report Number
    1627487-2024-12663
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    November 25, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT 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: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9242372. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 10097675. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 10097675.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THE DRG SYSTEM. INVESTIGATION WAS UNABLE TO DETERMINE 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
    2355391 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9157742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DRG IPG| DRG LEAD (3)