BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17971535 · Received October 19, 2023

    Report

    Report Number
    1627487-2023-04987
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG SLIMTIP IMPLANT LEAD, MODEL: MN10450-50A, UDI: (B)(4) , SERIAL: (B)(6) , BATCH: 9033152.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED DISCOMFORT AT ONE OF THE LEAD SITES DUE TO ONE OF THE LEAD WIRES HAD BEEN TOO CLOSE TO THE SURFACE OF THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN LEAD WAS REPOSITIONED AND IMPLANTED DEEPER TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD WAS CAUSING THE DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178520 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8847414 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG