BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 16903484 · Received May 10, 2023

    Report

    Report Number
    1627487-2023-02144
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 13, 2023
    Report Date
    July 15, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067025548
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT OF HIGH IMPEDANCE WAS NOT CONFIRMED. ANALYSIS OF THE LEAD A FOUND IT WAS RETURNED INCOMPLETE. ONLY THE TERMINAL END WAS RETURNED, AS SUCH A POSITIVE IDENTIFICATION OF THE LEAD MODEL WAS NOT ABLE TO BE MADE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL:MN10450-50A, UDI:(B)(4), SERIAL:(B)(6), BATCH:6151565.

    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.

    Description of Event or Problem · 0

    SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02146. IT WAS REPORTED THAT DUE TO HIGH IMPEDANCES ON TWO LEADS, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAYBE UNDERTAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579241 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-90A AB2309 05415067025548

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG.| DRG LEAD.