BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 16552655 · Received March 16, 2023

    Report

    Report Number
    1627487-2023-01160
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 16, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. DATE OF EXPLANT IS UNKNOWN. 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. 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: SLIM TIP LEAD, MODEL: MN10450-50A, SERIAL: (B)(4), UDI: (B)(4), BATCH: 6820291; COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN10450-50A, SERIAL: (B)(4), UDI: (B)(4), BATCH: 6225099; COMMON DEVICE NAME: SLIM TIP LEAD, MODEL: MN10450-50A, SERIAL: (B)(4), UDI: (B)(4), BATCH: 6820291. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DRG SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE IN 2019 DUE TO INEFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103694 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 6820291 05415067027153

    Patients

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