BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIAL DEVICE UNITIZED PROGRA

    MDR report key: 11791696 · Received May 7, 2021

    Report

    Report Number
    3013886523-2021-00215
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 23, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H6, H10. THE VALVE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. HOWEVER, THE POSSIBLE ROOT CAUSE FOR "INTESTINAL PUNCTURED, RETROGRADE MENINGITIS" COULD BE DUE TO ¿BPPC (BOWEL PERFORATION BY PERITONEAL CATHETERS) WHICH IS A LONG-TERM COMPLICATION OF PERITONEAL CATHETERS AND ARE TYPICALLY ENCASED IN A FIBROUS, CALCIFIED TUNNEL. THE CHRONIC-IRRITATIVE MECHANISM MAY BE THE MAIN REASON FOR LATE CASES OF BPPC AND IS CAUSED BY A BREAK IN THE CONTINUITY OF THE EPITHELIUM AROUND THE CONTACT SITE OF THE DISTAL CATHETER LEADING TO LOCAL INFLAMMATION, FIBROSIS, AND ADHERENCE OF THE CATHETER TO THE BOWEL WALL" AS PER MEDICAL ANALYSIS. FURTHERMORE, AS SPECIFIED IN THE IFU AT THE SECTION 'ADVERSE EVENTS': DEVICES FOR SHUNTING CSF MAY HAVE TO BE REPLACED AT ANY TIME DUE TO MEDICAL REASONS OR FAILURE OF THE DEVICE. KEEP PATIENTS WITH IMPLANTED SHUNT SYSTEMS UNDER CLOSE OBSERVATION FOR SYMPTOMS OF SHUNT FAILURE. COMPLICATIONS OF IMPLANTED SHUNT SYSTEMS INCLUDE MECHANICAL FAILURE, SHUNT PATHWAY OBSTRUCTION, INFECTION, FOREIGN BODY (ALLERGIC) REACTION TO IMPLANTS, AND CSF LEAKAGE ALONG THE IMPLANTED SHUNT PATHWAY. AN INFECTED SHUNT SYSTEM MAY SHOW REDNESS, TENDERNESS, OR EROSION ALONG THE SHUNT PATHWAY." TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE HAKIM PROGRAMMABLE VALVE WITH SG WAS IMPLANTED TO A PATIENT VIA L-P SHUNT SEVERAL YEARS AGO WITH AN UNKNOWN SETTING. THE ABDOMINAL CATHETER PUNCTURED AND ENTERED THE INTESTINAL TRACT. RETROGRADE MENINGITIS DEVELOPED AND ON (B)(6) 2021 THE SHUNT SYSTEM WAS REMOVED. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688851 SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 SILASCON LUMBAR CATH(KANEKA, PROD CODE: 702-JJ).