BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 9988473 · Received April 22, 2020

    Report

    Report Number
    2021898-2020-00129
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 22, 2020
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    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: [LIU AND SU 2020.PDF]

    Description of Event or Problem · 1

    JUNG-TUNG LIU, PEN-HUA SUA. THE EFFICACY AND LIMITATION OF LUMBOPERITONEAL SHUNT IN NORMAL PRESSURE HYDROCEPHALUS. CLINICAL NEUROLOGY AND NEUROSURGERY 193 (2020). DOI: 10.1016/J.CLINEURO.2020.105748 A B S T R A C T OBJECTIVE: TO INVESTIGATE WHETHER THE EFFICACY OF THE LUMBAR¿PERITONEAL (LP) SHUNT IS SUSTAINABLE, WE MEASURED THE OUTCOMES OF PATIENTS WITH IDIOPATHIC NPH (INPH) PREOPERATIVELY AND POSTOPERATIVELY. PATIENTS AND METHODS: WE RETROSPECTIVE REVIEWED RECORDS OF 58 PATIENTS WITH INPH FROM 2013 TO 2015. EXCLUSION OF 7 PATIENTS EXPIRED, 1 PATIENT SHUNT INFECTION, AND 8 PATIENTS WAS LOSS OF FOLLOW-UP. IN THE REMAINING 42 PATIENTS, THE MOOD, TALKING RESPONSE, MOVEMENT, ATTENTION, RECALLING MEMORY, AND MINI-MENTAL STATE EXAMINATION (MMSE), REPRESENTING PATIENT OUTCOMES, WERE MEASURED. ALL OF WHOM WERE FOLLOW-UP FOR 3 YEARS. RESULTS: MOOD (1.91 ± 0.30), TALKING RESPONSE (1.98 ± 0.15), MOVEMENT (1.71 ± 0.51), ATTENTION (1.95 ± 0.22), AND RECALLING MEMORY (1.86 ± 0.35) WERE SIGNIFICANTLY IMPROVED AFTER SURGERY (1 WEEK;P <(><<)> 0.0001). HOWEVER, THE INDICATORS SIGNIFICANTLY DECLINED AFTER 3 YEARS (MOOD: 0.31±0.52, TALKING RESPONSE: 0.50±0.59, MOVEMENT: 0.17±0.38, ATTENTION: 0.40±0.59, RECALLING MEMORY: 0.21±0.42). THE MMSE WAS ALSO SIGNIFICANTLY IMPROVED AFTER 3 MONTHS OF SURGERY (17.9 5±2.80 VS. 25.02±3.36; P <(><<)> 0.0001). HOWEVER, IT DECLINED AFTER 3 YEARS (17.83±3.66; P = 0.83). CONCLUSION: THE INPH IS CONSIDERED POTENTIALLY REVERSIBLE. OUR DATA SUPPORTED THAT THE LP SHUNT WAS EFFICIENT IN THE SHORT TERM. HOWEVER, THE NEUROLOGICAL DEGENERATION WAS STILL PROGRESSIVE. REPORTED EVENTS - 42 PATIENTS WERE ENROLLED, AND THE MOOD, TALKING RESPONSE, MOVEMENT, ATTENTION, RECALLING MEMORY, AND MMSE, REPRESENTING PATIENT OUTCOMES, WERE MEASURED. THE OUTCOME FOLLOW-UP DURATION WAS 3 YEARS. MOOD (1.91 ± 0.30), TALKING RESPONSE (1.98 ± 0.15), MOVEMENT (1.71 ± 0.51), ATTENTION (1.95 ± 0.22), AND RECALLING MEMORY (1.86 ± 0.35) WERE SIGNIFICANTLY IMPROVED 1 WEEK AFTER SURGERY, SUGGESTING THAT THE RECOVERY RATES WERE EFFICIENT IMMEDIATELY. HOWEVER, THE RECOVERY OUTCOMES DECLINED OVER TIME. THE INDICATORS SIGNIFICANTLY DECLINED AFTER 3 YEARS (MOOD: 0.31±0.52, TALKING RESPONSE: 0.50±0.59, MOVEMENT: 0.17±0.38, ATTENTION: 0.40±0.59, RECALLING MEMORY: 0.21±0.42). MOREOVER, THE MMSE (17.95±2.80 VS. 25.02±3.36) SIGNIFICANTLY IMPROVED AFTER 3 MONTHS OF SURGERY. HOWEVER, IT ALSO DECLINED OVER TIME. THE SIGNIFICANT DECLINE (17.83±3.66) WAS OBSERVED AFTER 3 YEARS COMPARED WITH THE PRE-OPERATION (FIG. 2; P= 0.83), INDICATING THAT THE RECOVERY OUTCOMES OF LP SHUNT FOR THE TREATMENT OF INPH WERE NOT SUSTAINABLE. THE NEUROLOGICAL DEGENERATION WAS STILL PROGRESSIVE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450258 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44420 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR