BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18580127 · Received January 25, 2024

    Report

    Report Number
    1627487-2024-00418
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 5, 2024
    Report Date
    March 4, 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 SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE THERAPY. 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

    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: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8830818.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON 13 FEBRUARY 2024 DURING WHICH THE ENTIRE SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173323 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8510488 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS IPG| SCS LEAD