BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18170645 · Received November 20, 2023

    Report

    Report Number
    1627487-2023-05511
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    October 23, 2023
    Report Date
    January 11, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST 1 OF 4 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9042812; COMMON DEVICE NAME: DRG LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9042812; COMMON DEVICE NAME: DRG LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9168220. DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION FROM THE SYSTEM. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023, WHERE A SECONDARY SYSTEM WAS IMPLANTED TO IMPROVE COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796221 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9042812 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other 3X DRG LEADS.| DRG IPG.