BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CODMAN HAKIM VALVE

    MDR report key: 7822248 · Received August 28, 2018

    Report

    Report Number
    1226348-2018-10616
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    September 20, 2011
    Report Date
    August 6, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: DEVICE AVAILABLE FOR EVALUATION. IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO PRODUCT OR 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 THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON RECEIPT OF NEW RELEVANT INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COCHLEAR IMPLANTATION FOR TOTAL DEAFNESS AFTER IPSILATERAL VENTRICULOPERITONEAL SHUNT SURGERY: TECHNICAL REPORT¿ BY YONG-HWI AN & SEONG JUN SONG & SANG WON YOON & JAE HOON KIM & HYUN JOON SHIM, PUBLISHED ACTA NEUROCHIR, DOI 10.1007/S00701-011-1180-5, 2011, IT WAS REPORTED THAT AFTER IMPLANTATION OF AN UNKNOWN HAKIM PROGRAMMABLE VALVE THE PATIENT HAD BILATERAL HEARING LOSS AND RECEIVED A COCHLEAR IMPLANT. PER THE ARTICLE: ¿COCHLEAR IMPLANTATION (CI) BECOMES MORE CHALLENGING WHEN A PROGRAMMABLE VENTRICULOPERITONEAL (VP) SHUNT IS PRESENT ON THE SAME SIDE OF THE HEAD. WE REPORT A SUCCESSFUL IPSILATERAL CI IN A PATIENT WHO SUFFERED BILATERAL HEARING LOSS AFTER SHUNT SURGERY. WE DESCRIBE THE CI CASE OF A (B)(6)-YEAR-OLD WOMAN WITH AN IMPLANTED VP SHUNT DEVICE, AND PERFORM A RETROSPECTIVE REVIEW OF THE CLINICAL, AUDIOLOGICAL, AND RADIOLOGICAL FEATURES, SURGICAL TECHNIQUES, AND POSTOPERATIVE FUNCTIONAL OUTCOMES.¿ AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS ARTICLE WAS DISCOVERED BY FDA SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665161 UNKNOWN CODMAN HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other