BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS

    MDR report key: 2033414 · Received March 24, 2011

    Report

    Report Number
    2021898-2011-00057
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 26, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXZ
    PMA / PMN Number
    K951258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 74 CM OF CATHETER WAS RETURNED SUTURED TO THE VALVE OUTLET. THE CATHETER WAS EVALUATED AND MET SPECIFICATIONS. THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO PT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT'S SYMPTOMS DID NOT IMPROVE AFTER VALVE IMPLANTATION. ACCORDING TO THE REPORT, A CONTRAST STUDY WAS PERFORMED AND THE VALVE'S PERFORMANCE LEVEL WAS CHANGED TO 0.5, HOWEVER, THERE WAS NO IMPROVEMENT IN THE PT'S SYMPTOMS. THE PT'S CONDITION IMPROVED AFTER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS JXZ MEDTRONIC NEUROSURGERY NA C67112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R