BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT TRIAL SLIM TIP LEAD, 50CM

    MDR report key: 16841245 · Received April 29, 2023

    Report

    Report Number
    1627487-2023-02009
    Event Type
    Injury
    Date Received
    April 29, 2023
    Date of Event
    February 27, 2023
    Report Date
    December 5, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027139
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT AND PATIENT WEIGHT ARE ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7974818.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY. IT IS UNKNOWN WHICH LEAD IS CAUSING THE INEFFECTIVE THERAPY. AS A RESULT, SURGERY MAY OCCUR IN THE FUTURE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212946 KIT TRIAL SLIM TIP LEAD, 50CM DRG TRIAL SLIM TIP LEAD PMP ABBOTT MEDICAL MN10350-50A 7974822 05415067027139

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other DRG IPG| DRG LEAD