BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UKNOWN SEPS KIT

    MDR report key: 10043187 · Received May 11, 2020

    Report

    Report Number
    2021898-2020-00136
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    March 31, 2020
    Report Date
    May 11, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. - ATTACHMENT: [ORTIZ 2020.PDF]

    Description of Event or Problem · 1

    ORTIMICHAEL 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 - THERE WERE 2 NON-FUNCTIONING DRAINS (NO DRAINAGE) FOR SEPS. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505364 UKNOWN SEPS KIT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC NEUROSURGERY UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR