BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 14792252 · Received June 23, 2022

    Report

    Report Number
    1627487-2022-03533
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    June 3, 2022
    Report Date
    July 18, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST 2 OF 4 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEADS, 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)(4), BATCH: 8296858. COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8070383. DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCING LEAD MIGRATION WAS REPORTED TO ABBOTT. THE PATIENT LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03534. IT WAS REPORTED THE PATIENTS RIGHT S2 AND S3 LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE MIGRATED LEADS WERE EXPLANTED AND REPLACED. IT IS UNKNOWN WHICH OF THE LEADS MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240038 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG SLIM TIP LEAD PMP ABBOTT MEDICAL MN10450-50A 8296858 05415067027153

    Patients

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