BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 16668665 · Received April 3, 2023

    Report

    Report Number
    1627487-2023-01428
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 7, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST ONE OF TWO LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD(S), THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT: PRODUCT FAMILY: DRG, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7791320.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A SYSTEM EXPLANT (MANUFACTURER REPORT NUMBER: 1627487-2023-01508) ON AN UNKNOWN DATE DUE TO INEFFECTIVE STIMULATION THE LEAD BROKE AND PARTIAL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265838 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 7791320 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other DRG IPG.