BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 19495381 · Received June 9, 2024

    Report

    Report Number
    1627487-2024-09247
    Event Type
    Injury
    Date Received
    June 9, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 23, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 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: KIT IMPLANTABLE SLIM TIP LEAD, 50CM, MODEL:,MN10450-50A, UDI: (B)(4), SERIAL: (B)(6) , BATCH: 9023672

    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 STIMULATION. THE INVESTIGATION DID NOT DETERMINE WHICH LEADS ATTRIBUTED TO THIS ISSUE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024, AND TWO LEADS WERE ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319078 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 9023672 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG IPG.| DRG LEAD.