BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 10556313 · Received September 18, 2020

    Report

    Report Number
    1723170-2020-02476
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    July 15, 2020
    Report Date
    September 18, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS AVERAGE AGE OF PATIENTS IN THE NAVIGATION SURGERY GROUP FOR THE ARTICLE. PATIENT GENDER IS THE MAJORITY GENDER OF PATIENTS IN THE NAVIGATION SURGERY GROUP FOR THE ARTICLE. PATIENT WEIGHT WAS NOT INCLUDED IN THE JOURNAL ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM SERIAL NUMBER IS NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE.) DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: AIJUN PENG , MING YANG , HAI ZHAO , YONGKANG WU , YI ZHAO & LIANGXUE ZHOU (2020): COMPARED WITH CONVENTIONAL PROCEDURES, AN IN TRAOPERATIVE NAVIGATION SYSTEM FOR VENTRICULOPERITONEAL SHUNTING VIA THE OCCIPITAL HORN IMPROVES OUTCOMES IN PATIENTS WITH HYDROCEPHALUS, BRITISH JOURNAL OF NEUROSURGERY, DOI: 10.1080/02688697.2020.1789555 ABSTRACT: BACKGROUND: VENTRICULOPERITONEAL SHUNTING (VPS) IS A COMMON NEUROSURGICAL PROCEDURE USED TO TREAT HYDROCEPHALUS. ALTHOUGH THE USE OF A NAVIGATION SYSTEM IN VPS ACHIEVES SUPERIOR RESULTS COMPARED WITH CONVENTIONAL SURGERY, THE RELATIONSHIPS AMONG CLINICAL SYMPTOMS, VENTRICULAR CATHETER PLACEMENT, CATHETER OBSTRUCTION, AND THE POSTOPERATIVE EVANS INDEX HAVE NOT BEEN CLEARLY REPORTED. METHODS: WE PERFORMED A RETROSPECTIVE STUDY OF 40 PATIENTS WITH VPS (THE NAVIGATION SURGERY GROUP) AND 31 PATIENTS WITH VPS (THE CONVENTIONAL SURGERY GROUP). CLINICAL DATA, FOLLOW-UP TIMES, CATHETERIZATION ACCURACY, POSTOPERATIVE OUTCOMES, CUMULATIVE SURVIVAL TIMES, AND CORRELATIONS BETWEEN CATHETER PLACEMENT AND OBSTRUCTION, SYMPTOM GRADE AND THE POSTOPERATIVE EVANS INDEX WERE ANALYZED. RESULTS: THIRTY-SEVEN PATIENTS EXPERIENCED OPTIMAL VENTRICULAR CATHETER PLACEMENT (GRADE 1), THREE EXPERIENCED SUBOPTIMAL PLACEMENTS (GRADE 2), AND NONE EXPERIENCED POOR VENTRICULAR CATHETER PLACEMENT (GRADE 3) IN THE NAVIGATION SURGERY GROUP. GREATER IMPROVEMENT IN POSTOPERATIVE SYMPTOMS (P < 0.001), INCLUDING LESS CATHETER READJUSTMENT (P < 0.001), WAS OBSERVED IN THE NAVIGATION SURGERY GROUP. A KAPLAN¿MEIER ANALYSIS SHOWED THAT THE CUMULATIVE CATHETER OBSTRUCTION-FREE SURVIVAL TIME WAS LONGER IN THE NAVIGATION SURGERY GROUP (P = 0.016). MOREOVER, CATHETER PLACEMENT WAS SIGNIFICANTLY CORRELATED WITH CATHETER OBSTRUCTION (P < 0.001). ADDITIONALLY, CATHETER OBSTRUCTION WAS SIGNIFICANTLY CORRELATED WITH THE SYMPTOM GRADE (P < 0.001) AND POSTOPERATIVE EVANS INDEX (P = 0.002). CONCLUSION: VPS FOR HYDROCEPHALUS VIA THE OCCIPITAL HORN WITH A NAVIGATION SYSTEM IS SUPERIOR TO THE CONVENTIONAL SURGICAL PROCEDURE IN TERMS OF CLINICAL OUTCOMES, THE PRECISION OF VENTRICULAR CATHETERIZATION, AND THE OCCURRENCE OF COMPLICATIONS. CATHETER OBSTRUCT ION-FREE SURVIVAL TIMES WERE LONGER IN THE NAVIGATION SURGERY GROUP AND CATHETER PLACEMENT WAS SIGNIFICANTLY CORRELATED WITH CATHETER OBSTRUCTION. GRADE 1 CATHETER PLACEMENT WAS DEFINED AS "OPTIMAL POSITION FREE-FLOATING IN CSF", GRADE 2 CATHETER PLACEMENT WAS DEFINED AS "TOUCHI NG CHOROID OR VENTRICULAR WALL OR NOT IN THE TARGET VENTRICLE", AND GRADE 3 CATHETER PLACEMENT WAS "CATHETER TIP TERMINATES IN PARENCHYMA". REPORTED EVENTS: 1. IN THE NAVIGATION SURGERY GROUP, A 68 YEAR-OLD MALE EXPERIENCED SUBOPTIMAL CATHETER PLACEMENT (GRADE 2 ACCURACY OF VENTRICULAR CA THETER). IT WAS NOTED THAT IN THE NAVIGATION GROUP, SUBOPTIMAL PLACEMENT WAS RECEIVED BECAUSE TOO MUCH CSF DRAINED DURING THE OPERATION, WHICH CAUSED THE BRAIN TO SHIFT. HOWEVER, THE ACCURACY ERROR WAS LESS THAN 2 MILLIMETERS ACCORDING TO A COMPARISON OF THE DEPTH OF THE INSERTED VENTRICULAR CATHETER ON POSTOPERATIVE CT AND THE DEPTH DETERMINED BY THE NAVIGATIONAL SOFTWARE USED DURING PREOPERATIVE PLANNING. 2. IN THE NAVIGATION SURGERY GROUP, A 53 YEAR OLD FEMALE EXPERIENCED SUBOPTIMAL CATHETER PLACEMENT (GRADE 2 ACCURACY OF VENTRICULAR CATHETER). IT WAS NOTED THAT IN THE NAVIGATION GROUP, SUBOPTIMAL PLACEMENT WAS RECEIVED BECAUSE TOO MUCH CSF DRAINED DURING THE OPE RATION, WHICH CAUSED THE BRAIN TO SHIFT. HOWEVER, THE ACCURACY ERROR WAS LESS THAN 2 MILLIMETERS ACCORDING TO A COMPARISON OF THE DEPTH OF THE INSERTED VENTRICULAR CATHETER ON POSTOPERATIVE CT AND THE DEPTH DETERMINED BY THE NAVIGATIONAL SOFTWARE USED DURING PREOPERATIVE PLANNING. 3. IN THE NAVIGATION SURGERY GROUP, A 58 YEAR OLD MALE EXPERIENCED SUBOPTIMAL CATHETER PLACEMENT (GRADE 2 ACCURACY OF VENTRICULAR CA THETER). IT WAS NOTED THAT IN THE NAVIGATION GROUP, SUBOPTIMAL PLACEMENT WAS RECEIVED BECAUSE TOO MUCH CSF DRAINED DURING THE OPERATION, WHICH CAUSED THE BRAIN TO SHIFT. HOWEVER, THE ACCURACY ERROR WAS LESS THAN 2 MILLIMETERS ACCORDING TO A COMPARISON OF THE DEPTH OF THE INSERTED VENTRICULAR CATHETER ON POSTOPERATIVE CT AND THE DEPTH DETERMINED BY THE NAVIGATIONAL SOFTWARE USED DURING PREOPERATIVE PLANNING. SEE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017248 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR