BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 20316099 · Received September 26, 2024

    Report

    Report Number
    1627487-2024-11160
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    September 4, 2024
    Report Date
    November 26, 2024
    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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    A4 CORRECTION: THE PATIENT'S WEIGHT WAS UPDATED.

    Additional Manufacturer Narrative · 0

    SECTION A4 PATIENT WEIGHT HAS NOT YET BEEN PROVIDED. THE ALLEGATION IS AGAINST 1 OF 4 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: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982307. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982307. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9202240.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY ONE LEAD MIGRATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INADEQUATE THERAPY FROM THEIR DRG SYSTEM. PROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE SYSTEM WAS EXPLANTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371429 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DGR LEAD PMP ABBOTT MEDICAL MN10450-50A 7563059 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other DRG IPG.| DRG LEAD (X2).| DRG LEAD.