BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18785317 · Received February 26, 2024

    Report

    Report Number
    1627487-2024-07224
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 7, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT HAD THEIR SYSTEM EXPLANTED DUE TO INEFFECTIVE STIMULATION WAS REPORTED TO ABBOTT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT IS ESTIMATED. 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: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8860742 COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8860742 COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8860742

    Additional Manufacturer Narrative · 0

    H6 - INVESTIGATION CONCLUSIONS CODE "24 - CAUSE TRACED TO INTENTIONAL OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE" HAS BEEN REMOVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07225 IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING AND REPROGRAMMING WAS ATTEMPTED TO NO AVAIL. TARGETED PAIN PATTERN IS PENIS AND RECTUM. THERE ARE NO LOW OR HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146321 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8673674 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other DRG LEAD (3)