BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 21911021 · Received April 25, 2025

    Report

    Report Number
    1627487-2025-01993
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    April 18, 2025
    Report Date
    April 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE ALLEGATION IS AGAINST 1 OF 4 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 SLIMTIP IMPLANT LEAD KIT, ABT, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7791332. COMMON DEVICE NAME: 50CM SLIMTIP IMPLANT LEAD KIT, ABT, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: UNK, BATCH: UNK. COMMON DEVICE NAME: 90CM SLIMTIP IMPLANT LEAD KIT, ABT, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7113351.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED VIA SURGICAL INTERVENTION ON (B)(6) 2025. IT IS UNKNOWN WHICH LEAD CAUSED/CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347127 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 6994709 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG| DRG LEAD (X3)