BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 15422418 · Received September 14, 2022

    Report

    Report Number
    1627487-2022-04570
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    May 10, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: MFG 3/31/2021 IMPLANT: (B)(6) 2021, COMMON DEVICE NAME: DGG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7909301. MFG 5/26/2020, IMPLANT: (B)(6) 2021, COMMON DEVICE NAME: DGG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7528487. MFG 6/3/2021, IMPLANT: (B)(6) 2021, COMMON DEVICE NAME: DGG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7999790. 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 THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE ENTIRE DRG SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD WAS INEFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675332 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 7528487 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other DRG IPG| DRG LEAD (X4)