BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17777040 · Received September 19, 2023

    Report

    Report Number
    1627487-2023-04481
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    September 10, 2023
    Report Date
    September 26, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    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

    A PATIENT EXPERIENCING INEFFECTIVE STIMULATION WAS REPORTED TO ABBOTT. A PATIENT UNDERWENT A REVISION. AN ADDITIONAL DRG LEAD IS BEING ADDED TO SYSTEM FOR BETTER COVERAGE. THE PHYSICIAN ATTEMPTED TO PUT ANOTHER LEAD AT L1, BUT HE WASN'T ABLE TO GET ACCESS, SO HE TRIED T12. THE PHYSICIAN COULDN'T GET ACCESS THERE EITHER, SO HE ABORTED THE CASE. NOTHING WAS EXPLANTED AND THE PATIENT STILL HAD A LEAD AT L2. 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

    B3-DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8042800. COMMON DEVICE NAME: DRG: LEAD, MODEL: MN20450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8145643.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 TO ADD A LEAD. HOWEVER, DURING THE SURGERY THE SURGEON WAS UNABLE TO ADD ANOTHER LEAD DUE TO PATIENT'S ANATOMY. ADDITIONAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD WAS ATTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584716 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8042800 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other DRG IPG| DRG LEAD| DRG LEAD