BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 11067867 · Received December 23, 2020

    Report

    Report Number
    3002648230-2020-00679
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    May 24, 2020
    Report Date
    December 23, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE PATIENT WEIGHT WAS NOT PROVIDED IN THE ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE UNIQUE IDENTIFIER WAS NOT AVAILABLE AT THE TIME OF REPORTING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.THE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NOTARIS, M., CORRIVETTI, F., CATAPANO, G. THREE-DIMENSIONAL VERSUS 2-DIMENSIONAL ENDOSCOPIC THIRD VENTRICULOSTOMY: SURGICAL RESULTS OF A PRELIMINARY COMPARATIVE STUDY. WORLD NEUROSURG. 2020. 141:E530-E536. HTTPS://DOI.ORG/10.1016/J.WNEU.2020.05.223 BACKGROUND:THREE-DIMENSIONAL (3-D) ENDOSCOPES HAVE BEEN WIDELY USED FOR A LARGE VARIETY OF APPROACHES IN NEUROSURGICAL PRACTICE. HOWEVER, IN THE LAST DECADE, 3-D SCOPES WERE BARELY USED FOR VENTRICULAR SURGERY. IN THIS STUDY, WE ILLUSTRATED OUR PRELIMINARY EXPERIENCE WITH A 3-D ENDOSCOPE FOR THIRD VENTRICULOSTOMY USING NEW DEDICATED ENDOSCOPIC EQUIPMENT. METHODS: OVER A 12-MONTH PERIOD, A HIGH-DEFINITION 3-D ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) WAS PERFORMED IN 14 PATIENTS WITH OBSTRUCTIVE HYDROCEPHALUS. PATIENTS WERE FOLLOWED PROSPECTIVELY AND COMPARED RETROSPECTIVELY WITH A MATCHED GROUP OF 16 SIMILAR PATIENTS WHO UNDERWENT ETV WITH A STANDARD 2-DIMENSIONAL (2-D) ENDOSCOPE. SURGICAL OUTCOME AND INTRA- AND POSTOPERATIVE COURSE WERE RETROSPECTIVELY REVIEWED. RESULTS: 3-D ETV PROVIDED EXCELLENT SURGICAL RESULTS, AND NO SIGNIFICANT DIFFERENCE WAS SHOWN IN TERMS OF OUTCOME, COMPLICATION, AND LENGTH OF HOSPITALIZATION BETWEEN THE 2 GROUPS. MOREOVER, OPERATIVE TIME (MINUTES) WAS SIGNIFICANTLY SHORTER IN THE 3-D GROUP THAN THE 2-D ETV GROUP (19.9 4.8 VS. 22.9 1.4, RESPECTIVELY; P <(><<)> 0.05), AND THE USE OF THE 3-D ENDOSCOPE PROVIDED SUBJECTIVE IMPROVEMENTS OF DEPTH PERCEPTION ,HAND-EYE COORDINATION, AND SURGEON COMFORT. CONCLUSIONS: OUR PRELIMINARY STUDY CLEARLY DEMONSTRATED THE EFFECTIVENESS OF 3-D ETV AND PROVIDED A SIGNIFICANT REDUCTION OF OPERATI VE TIME. DEPTH INFORMATION FROM THE 3-D SCOPE APPEARS TO FACILITATE RAPID AND STABLEETV MANEUVERS, REPRESENTING A CRITICAL DEVELOPMENT THAT MAY BECOME A VALUABLE TOOL FOR NEUROENDOSCOPY. REPORTABLE EVENTS: ONLY 2 PATIENTS DID NOT PRESENT ANY CLINICAL IMPROVEMENT; BOTH UNDERWENT POSTOPERATIVE CINE MRI THAT CONFIRMED STOMA PATENCY, AND ONE OF THEM UNDERWENT VENTRICULOPERITONEAL SHUNT RESULTING IN PROGRESSIVE POSTOPERATIVE CLINICAL IMPROVEMENT. 1 PATIENT IN WHICH A SLIGHT VENOUS BLEEDING OCCURRED AFTER PERFORATION OF THE THIRD VENTRICLE FLOOR. THREE PATIENTS PRESENTED A POOR POSTOPERATIVE OUTCOME, AND 1 OF THEM UNDERWENT SECOND ETV SURGERY FOR THE OCCLUSION OF THE STOMA AND SUCCESSIVE VENTRICULOPERITONEAL SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534349 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC CRYOCATH LP UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other