BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 90CM

    MDR report key: 22451962 · Received July 8, 2025

    Report

    Report Number
    1627487-2025-03394
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    March 7, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027160
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. SECTION A4: DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION (WEIGHT); HOWEVER, NO FURTHER INFORMATION WAS RECEIVED. THE ALLEGATION IS AGAINST 2 OF 3 CERVICAL DRG 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: KIT IMPLANTABLE SLIM TIP LEAD, 90CM, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(6); BATCH:6813185.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY WITH THEIR DRG SYSTEM. DIAGNOSTICS INDICATED HIGH IMPEDANCES ON TWO OF THE CERVICAL DRG LEADS. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025, WHEREIN THE IMPEDED LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEADS CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121523 KIT IMPLANTABLE SLIM TIP LEAD, 90CM DRG LEAD PMP ABBOTT MEDICAL MN10450-90A 6379261 05415067027160

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other DRG IPG.| DRG LEAD X2.