BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 14883584 · Received July 1, 2022

    Report

    Report Number
    1627487-2022-03663
    Event Type
    Injury
    Date Received
    July 1, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027160
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST 1OF 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, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8041925.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED LEG WEAKNESS AFTER IMPLANTING A 2 LEAD DRG SYSTEM AT LEFT L3, L4. SYMPTOMS PERSISTED AND AS A RESULT, PATIENT WAS HOSPITALIZED. DIAGNOSTIC TESTS AND IMAGING REVEALED NO SPINAL INJURIES. FOLLOW-UP INFORMATION INDICATED PATIENT IS STABLE, REPORTEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549433 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A 7697478 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O