BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18441306 · Received January 3, 2024

    Report

    Report Number
    1627487-2024-00038
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 8, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3-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), LOT: 8860739.

    Additional Manufacturer Narrative · 0

    AN EVENT OF INFECTION WAS REPORTED TO ABBOTT. IT WAS CONVEYED THAT THE INFECTION ORIGINATES AT THE S1 LEAD SITE(S). THE ENTIRE SYSTEM WAS EXPLANTED; HOWEVER, NO EXPLANTED PRODUCTS WERE RETURNED FOR ANALYSIS. AS A RESULT, A DEVICE HISTORY RECORD WAS PERFORMED TO REVIEW AND CONFIRM THE STERILITY OF THE LEAD(S). BASED ON THE DOCUMENTS REVIEWED, THE SOURCE OF THE INFECTION REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE S1 LEAD SITE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586218 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8860739 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other DRG IPG| EXTENSION (X2)