BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 17393079 · Received July 25, 2023

    Report

    Report Number
    1627487-2023-03555
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THE ALLEGATION IS AGAINST 1 OF 3 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 SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9023672. COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9023672.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW DAYS AFTER A LEAD REPLACEMENT PROCEDURE, THE PATIENT REPORTED A HEADACHE DUE TO A CSF LEAK AND SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN A BLOOD PATCH OCCURRED. FOLLOW UP INDICATED THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THEIR HEADACHE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338381 KIT IMPLANTABLE SLIM TIP LEAD, 50CM DRG LEAD PMP ABBOTT MEDICAL MN10450-50A 8867149 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other DRG IPG| DRG LEAD X 2