BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT TRIAL SLIM TIP LEAD, 50CM

    MDR report key: 18656158 · Received February 6, 2024

    Report

    Report Number
    1627487-2024-00611
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 31, 2022
    Report Date
    September 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027139
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    505

    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

    DATE OF EVENT IS ESTIMATED. DATE OF EXPLANT IN UNKNOWN. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG TRIAL LEAD, MODEL: MN10350-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8070382.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 MEDICAL DEVICE PROBLEM CODE.

    Description of Event or Problem · 0

    USER FACILITY MEDWATCH (REFERENCE MW5149570) RECEIVED THAT STATES ¿DURING MY TRIAL DRG IMPLANT IT OVERHEATED MULTIPLE TIMES CAUSING BURN BLISTERY ON MY BACK, THEN THEY HAD TO HAVE EMERGENCY REMOVAL.¿ NOTE: ISSUE REPORTED FOR THE PERMANENT IMPLANT IS REPORTED UNDER RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00612 AND ISSUE RELATED TO LEAD FRACTURE IS REPORTED UNDER:1627487-2023-00390. INVESTIGATION UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764308 KIT TRIAL SLIM TIP LEAD, 50CM DRG TRIAL LEAD PMP ABBOTT MEDICAL MN10350-50A 8044104 05415067027139

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other DRG TRIAL LEAD