BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT TRIAL SLIM TIP LEAD, 50CM

    MDR report key: 10776159 · Received November 2, 2020

    Report

    Report Number
    1627487-2020-32884
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 5, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027139
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT #1 PI MAIN [PI-2020-0192981-01]. IT WAS REPORTED TO ABBOTT THAT DURING A TRIAL PROCEDURE, A CEREBRAL SPINAL FLUID (CSF) LEAK OCCURRED. THE DRG TRIAL LEAD HAD BEEN PLACED AT L5 WHEN THE WET TAP OCCURRED. THE PHYSICIAN PERFORMED A BLOOD PATCH AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT SHOW ANY SYMPTOMS. ALL INFORMATION PERTAINING TO THIS EVENT HAS BEEN REVIEWED, ISSUE WAS NOT PRODUCT RELATED, AND NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED A CEREBROSPINAL FLUID (CSF) LEAK OCCURRED WHILE THE PHYSICIAN WAS ATTEMPTING TO PLACE THE LEAD AT L5, DURING A DRG TRIAL IMPLANT PROCEDURE THAT TOOK PLACE ON (B)(6) 2020. AS A RESULT, THE PHYSICIAN PERFORMED A BLOOD PATCH AND THE PATIENT WAS ASYMPTOMATIC AND PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239148 KIT TRIAL SLIM TIP LEAD, 50CM DRG TRIAL SLIM TIP LEAD PMP ABBOTT MEDICAL MN10350-50A 6841437 05415067027139

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other