BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18700367 · Received February 13, 2024

    Report

    Report Number
    1627487-2024-00801
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    December 8, 2023
    Report Date
    March 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCING INEFFECTIVE STIMULATION WAS REPORTED TO ABBOTT. THE PHYSICIAN WAS UNABLE TO REMOVE ONE LEAD AND REMAINS IMPLANTED. AN ADDITIONAL LEAD WAS IMPLANTED. THERAPY RESTORED POST-OP. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    SECTION A4: DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN PATIENT WEIGHT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. SECTION B3: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF TWO LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8081978.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE RELIEF FROM THEIR DRG SYSTEM. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PHYSICIAN WAS UNABLE TO REMOVE THE PATIENT'S S1 DRG LEAD. THE PHYSICIAN ELECTED TO LEAVE THE LEAD CONNECTED IN PLACE AND ADD A NEW S1 LEAD TO THE PATIENT'S SYSTEM. THERAPY WAS RESTORED POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81112 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 7828130 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DRG IPG(X1).| DRG LEAD (X1).