BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 18369489 · Received December 20, 2023

    Report

    Report Number
    1627487-2023-06030
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    December 4, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE 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: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8583633. COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4) , SERIAL: (B)(6), BATCH: 8583633. COMMON DEVICE NAME: LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 8880353. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION AND A NEW TRIAL SYSTEM WAS IMPLANTED ON (B)(6) 2023. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD CONTRIBUTED TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035791 KIT IMPLANTABLE SLIM TIP LEAD, 50CM Dorsal root ganglion stimulator for pain relief PMP ABBOTT MEDICAL MN10450-50A 8860739 05415067027153

    Patients

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