BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 16636421 · Received March 29, 2023

    Report

    Report Number
    1627487-2023-01384
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 23, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD: MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8081976.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO ONE OF THE LEADS HAD FRACTURE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE FRACTURED LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POSTOP. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008177 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 8081976 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other DRG IPG