BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS

    MDR report key: 3241693 · Received July 22, 2013

    Report

    Report Number
    2021898-2013-00248
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 74.5 CM OF THE PERITONEAL CATHETER WAS RETURNED. THE CATHETER MET THE REQUIREMENTS FOR PATENCY AND LEAK TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION HAS NOT BEEN COMPLETED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT UNDERWENT A VP SHUNT PROCEDURE FOR POST-SUBARACHNOIDAL HEMORRHAGE HYDROCEPHALUS. ACCORDING TO THE REPORT, CONTRAST STUDY OF THE SHUNT SHOWED NO ANOMALIES. REPORTEDLY, THE SHUNT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340716 PERITONEAL CATHETER WITH BIOGLIDE, 8 SLITS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D37433

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R