BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 9988430 · Received April 22, 2020

    Report

    Report Number
    2021898-2020-00128
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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

    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 - 1 PATIENT EXPERIENCED A SHUNT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449160 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 Other