BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17010420 · Received May 26, 2023

    Report

    Report Number
    1627487-2023-02399
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    April 13, 2023
    Report Date
    July 6, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 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: 50CM IMPLANT LEAD KIT, SLIM TIP, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6840452.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D4, D6A, AND H4 HAVE BEEN UPDATED TO REFLECT THE CORRECT DEVICE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WILL BE UNDERTAKEN IN THE FUTURE TO ADDRESS THIS ISSUE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE. HOWEVER, DUE TO THE PATIENT'S ANATOMY THE PHYSICIAN WAS UNABLE TO REMOVE THE NON-FUNCTIONING LEAD. LEAD WAS LEFT IN-SITU. NO FURTHER INTERVENTION IS PLANNED AT THIS TIME REGARDING THE LEAD THAT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848640 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 6840452 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other SCS IPG| SCS LEAD| SCS LEAD EXTENSION