BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SEPS KIT

    MDR report key: 10043233 · Received May 11, 2020

    Report

    Report Number
    2021898-2020-00137
    Event Type
    Injury
    Date Received
    May 11, 2020
    Date of Event
    March 31, 2020
    Report Date
    May 11, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    ERL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    MICHAEL ORTIZ, MD, PATRICK BELTON, MD, MATTHEW BURTON, MD, N. SCOTT LITOFSKY, MD. SUBDURAL DRAIN VS SUBDURAL EVACUATING PORT SYSTEM FOR THE TREATMENT OF NON-ACUTE SUBDURAL HEMATOMAS: A SINGLE- CENTER RETROSPECTIVE COHORT STUDY, WORLD NEUROSURGERY (2020), DOI: 10. 1016/J.WNEU.2020.03.226. BACKGROUND: SUBDURAL DRAIN (SDD) AND SUBDURAL EVACUATING PORT SYSTEM (SEPS) ARE BEDSIDE OPTIONS FOR MANAGEMENT OF NON-ACUTE SUBDURAL HEMATOMAS (SDH). THESE INTERVENTIONS HAVE NOT BEEN COMPARED WITH EACH OTHER. OUR OBJECTIVE IS TO COMPARE THE NEED FOR SECOND BEDSIDE PROCEDURE, NEED FOR CRANIOTOMY, COMPLICATION RATE AND OTHER OUTCOMES RELATED TO BEDSIDE DRAINAGE OF SDH WITH SDD OR SEPS. WE HYPOTHESIZED THAT SDD WOULD BE ASSOCIATED WITH SUPERIOR OUTCOMES TO SEPS. METHODS: DATABASE QUERIES AND DIRECT PATIENT CHART REVIEWS WERE USED TO GATHER PATIENT DATA. T-TESTS, FISHER¿S EXACT TESTS, AND PROPORTIONAL ODDS MODELS WERE PERFORMED. RESULTS: OF 41 SDD AND 25 SEPS, BASELINE CHARACTERISTICS WERE SIMILAR EXCEPT MORE ISODENSE SDHS WERE PRESENT IN SDD (P = .0312). SEPS WAS ASSOCIATED WITH SIGNIFICANT RISK OF REQUIRING A SECOND BEDSIDE PROCEDURE (OR 3.2381, 99% CI: 1.0345 ¿ 10.1355) RELATIVE TO SDD. NEED FOR CRANIOTOMY DID NOT DIFFER BETWEEN GROUPS (12.1% SDD VS 16% SEPS; P = .721). THE COMPLICATION RATE WAS SIMILAR BETWEEN GROUPS (2.4% SDD VS 12% SEPS; P = .1484). SYMPTOM RESOLUTION, CONDITION AT LATEST FOLLOW-UP, AND POST-HOSPITAL DISPOSITION WAS SIMILAR BETWEEN GROUPS, BUT SEPS WAS ASSOCIATED WITH LONGER INTENSIVE CARE UNIT (ICU) AND TOTAL HOSPITAL LENGTH OF STAY (LOS) (P = .02 AND .04, RESPECTIVELY). CONCLUSION: SEPS WAS ASSOCIATED WITH HIGHER RISK FOR NEED OF SECOND BEDSIDE PROCEDURE AND LONGER ICU AND HOSPITAL LOS THAN SDD, ALTHOUGH NOT INCREASED NEED FOR CRANIOTOMY. ADDITIONAL STUDIES ARE NEEDED TO CONFIRM OUR FINDINGS AND DETERMINE IF SDD MAY BE MORE EFFECTIVE THAN SEPS FOR THE TREATMENT OF NON-ACUTE SDH. REPORTED EVENTS> - THE COMPLICATION RATE OF THE SEPS WAS 12%. THE ONLY ADVERSE EVENTS RELATED TO THE PROCEDURE WERE ACUTE HEMORRHAGES. NONE OF THESE HEMORRHAGES WERE FATAL, BUT ONE RELATED TO SEPS PLACEMENT REQUIRED CRANIOTOMY FOR HEMORRHAGE EVACUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507842 UNKNOWN SEPS KIT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC NEUROSURGERY UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R