BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 5106070 · Received September 25, 2015

    Report

    Report Number
    2021898-2015-00361
    Event Type
    Injury
    Date Received
    September 25, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL DEVICE INFORMATION. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. LITERATURE ARTICLE: POSTHEMORRHAGIC HYDROCEPHALUS IN EXTREMELY LOW BIRTH WEIGHT INFANTS: OMMAYA RESERVOIR VS. VENTRICULOPERITONEAL SHUNT RALF-BODO TRÖBS, VOLKER SANDER CHILDS NERV SYST (2015) 31:1261¿1266 DOI 10.1007/S00381-015-2754-Y. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY IDENTIFIED THE FOLLOWING INFORMATION UPON REVIEW OF SCIENTIFIC LITERATURE: TEMPORARY INSERTION OF AN OMMAYA RESERVOIR WAS PERFORMED IN 18 INFANTS. TEMPORARY INSERTION OF A VENTRICULAR CATHETER CONNECTED TO A SUBCUTANEOUS CSF RESERVOIR WAS PERFORMED AT THE AGE OF 32.5 DAYS. THE CSF RESERVOIR WAS LEFT IN SITU FOR 55 DAYS. FOR 15 PATIENTS IN THIS GROUP, THE CSF RESERVOIR WAS EXPLANTED AND REPLACED WITH A VPS. NO CSF INFECTIONS WERE OBSERVED; HOWEVER, ONE INFANT WAS TREATED WITH EXTERNAL DRAINAGE SHORTLY AFTER CONVERSION TO VPS. FOR 1 INFANT IN THIS GROUP, DYSFUNCTION OF THE CSF RESERVOIR LED TO EARLY REPLACEMENT WITH A VPS. IN 2 OF 17 PATIENTS, HYDROCEPHALUS ARRESTED (1 OMMAYA RESERVOIR WAS REMOVED, AND 1 WAS LEFT IN SITU, READY FOR EXPLANTATION); 1 PATIENT WITH A CSF RESERVOIR CHANGED CAREGIVERS AND WAS LOST TO FOLLOW-UP. IN CONCLUSION, EARLY INSERTION OF CSF RESERVOIR ALLOWED STABILIZATION OF THE INFANTS AND THUS POSTPONEMENT OF PERMANENT VPS INSERTION. HOWEVER, IN A SUBGROUP OF PATIENTS, PHH DEVELOPS OVER A MORE PROLONGED COURSE, AND VPS INSERTION CAN BE PERFORMED INITIALLY WITHOUT THE NEED FOR CSF RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635447 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00186 DA Hospitalization| R