BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 15801365 · Received November 15, 2022

    Report

    Report Number
    1627487-2022-06208
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 15, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT WAS ESTIMATED. 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: DRG SLIM TIP LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 6940411; COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7073042.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A SYSTEM EXPLANT DUE TO INEFFECTIVE STIMULATION. INVESTIGATION WAS UNABLE TO DETERMINE WHICH LEAD ATTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757879 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 6820291 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG