BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18248504 · Received December 1, 2023

    Report

    Report Number
    1627487-2023-05695
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    August 11, 2023
    Report Date
    February 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED. 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: 6820291 [L1 LEAD]. COMMON DEVICE NAME: DRG LEAD, MODEL:MN10450-50A, UDI: (B)(4) , SERIAL: (B)(6) , BATCH: 6820291 [S1 LEAD].

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A PRODUCT 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.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: 1627487-2023-05694.IT WAS REPORTED THAT THE PATIENT'S IPG WAS UNABLE TO GET INTO MRI MODE AND THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. FURTHER INVESTIGATION REVEALED HIGH IMPEDANCE ON L1 LEAD AND MIGRATION OF S2 LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHERE THE L1 LEAD WAS EXPLANTED AND S2 LEAD WAS REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED AND WHICH LEAD HAD HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399329 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 6820291 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other DRG IPG.| DRG LEAD (X2).