BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV W/UNTZD CAT

    MDR report key: 7169360 · Received January 5, 2018

    Report

    Report Number
    1226348-2018-10029
    Event Type
    Injury
    Date Received
    January 5, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THREE POTENTIAL LOT NUMBERS WERE PROVIDED: CVCCNJ, 122310, 130588. WHILE WE WERE NOT ABLE TO IDENTIFY THE SPECIFIC LOT INVOLVED IN THIS EVENT, REVIEW OF THE PROVIDED THREE NUMBERS FOUND THERE WERE NO DISCREPANCIES IN ANY OF THESE LOTS PRIOR TO DISTRIBUTION OF THE DEVICES. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED TO THE PATIENT VIA LP-SHUNT FOR INPH. JUST AFTER THE SURGERY, ALTHOUGH GAIT DISORDER WAS IMPROVED, THE KINK OF THE CATHETER WAS CONFIRMED WHEN EXAMINED DUE TO GAIT DISORDER DETERIORATION. ON (B)(6) 2017: THE SURGERY WAS PERFORMED FOR REPLACEMENT OF THE CATHETER. EVEN IT WAS IMPROVED ONE, THE PATIENT COMPLAINED A STOMACH ACHE ON (B)(6), AND HE CAME TO THE SITE. THE INFECTION WAS SUSPECTED AND THE SURGERY WAS PERFORMED ON (B)(6). THE CELL NUMBER WAS ABOUT 300-400. HE WAS FOLLOW-UP WITHOUT SHUNTING BUT HE WANTED THE SHUNTING BECAUSE WALKING WILL BE IMPROVED. ON (B)(6) 2017: THE REVISION SURGERY WAS PERFORMED VIA VP SHUNTWITH THE VALVE (82-8802). ON (B)(6) 2017: HE WAS DISCHARGED WITH GOOD PROGRESS IN WALKING IMPROVEMENT CONSIDERATION1: THE NUMBER OF CELLS ALREADY HAD 300-400 WHEN REVISING THE CATHETER ON (B)(6), SO IT MIGHT HAVE BEEN INFECTED AT THIS TIME. IT MAY BE THAT CSF STAGNATED DUE TO KINK AND THE NUMBER OF CELLS INCREASED CONSIDERATION2: BECAUSE THE SIZE OF THE VALVE WAS LARGER THAN CHPV, IT MAY BE CONSIDERED AS ONE FACTOR THAT THE SHAPE WAS MORE INFECTIOUS THAN CHPV. (THIS SITE USES MICRO A VALVE 82-3112 FOR LP SHUNT, ESPECIALLY THE DIFFERENCE IN SIZE COMPARED WITH CERTAS WAS OBVIOUS) (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13286 CERTAS INLINE VLV W/UNTZD CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention