BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO VALVE, PRECISION, W/ UTILIZED DISTAL CATHETER

    MDR report key: 3821450 · Received May 20, 2014

    Report

    Report Number
    1226348-2014-11651
    Event Type
    Injury
    Date Received
    May 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK973774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND PRODUCT LOT AND/OR SERIAL NUMBERS ARE NOT AVAILABLE; THEREFORE, EVALUATION COULD NOT BE PERFORMED. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME; HOWEVER, IF THE COMPLAINT SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE REOPENED AND THE RESPECTIVE EVALUATION PERFORMED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    A MOTHER CALLED ON (B)(6) 2014, STATING THAT HER CHILD HAD A CODMAN SHUNT IMPLANTED APPROXIMATELY ONE YEAR AGO, AND HAD TO BE EXPLANTED BECAUSE SOME COMPLICATIONS. ADDITIONALLY, SHE INFORMED THAT THE SHUNT WAS CRACKED AND MALFUNCTIONING. THE DEVICE WAS EXPLANTED AT (B)(6). SHE WOULD LIKE TO HAVE THE EVALUATION RESULTS; HOWEVER, SHE DID NOT HAVE THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION. SHE DECLINED TO PROVIDE ANY OTHER INFORMATION INCLUDING PHONE NUMBER AND/OR ANY OTHER CONTACT INFORMATION. (B)(6) 2014 - THE SALES REP. IN THE AREA CONTACTED THE NEURO COORDINATOR AT THIS ACCOUNT REGARDING THIS ISSUE. (B)(6) 2014 - THE SALES REP. CALLED TODAY AND INFORMED THAT THE NEURO COORDINATOR AT THIS ACCOUNT CALLED BACK; HOWEVER, DOES NOT HAVE ANY INFORMATION REGARDING THIS ISSUE, AND DOES NOT HAVE ANY DEVICES TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299755 MICRO VALVE, PRECISION, W/ UTILIZED DISTAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention