BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 16187512 · Received January 17, 2023

    Report

    Report Number
    1627487-2023-00205
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    November 15, 2022
    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
    AZ, 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. THE ALLEGATION IS AGAINST 1 OF 2 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: LEAD, MODEL: MN10450-50A , UDI:(B)(4) , SERIAL:(B)(4), BATCH:7231218.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. TROUBLESHOOTING REVEALED HIGH IMPEDANCE ON ONE LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655831 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 7231218 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other DRG IPG.| DRG LEAD.