BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 6201575 · Received December 22, 2016

    Report

    Report Number
    1226348-2016-10879
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    June 27, 2016
    Product Code
    JXG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. 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

    UDI INFORMATION NOT AVAILABLE. NO PRODUCT CODE OR DEVICE INFORMATION PROVIDED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COMPARISON OF ELEVATED INTRACRANIAL PRESSURE PULSE AMPLITUDE AND DISPROPORTIONATELY ENLARGED SUBARACHNOID SPACE (DESH) FOR PREDICTION OF SURGICAL RESULTS IN SUSPECTED IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS.¿ BY GARCIA-ARMENGOL R.; DOMENECH S.; BOTELLA-CAMPOS C.; GONCALVES F.J.; MENENDEZ B.; TEIXIDOR P.; MUNOZ-NARBONA L.; RIMBAU, PUBLISHED ACTA NEUROCHIRURGICA. 158 (11) (PP 2207-2213), 2016., THE AUTHORS COMPARE THE PROGNOSTIC VALUE OF PULSE AMPLITUDE ON INTRACRANIAL PRESSURE (ICP) MONITORING AND DISPROPORTIONATELY ENLARGED SUBARACHNOID SPACE HYDROCEPHALUS (DESH) ON MAGNETIC RESONANCE IMAGING (MRI) FOR PREDICTING SURGICAL BENEFIT AFTER SHUNT PLACEMENT IN IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH). THERE WERE 118 CONSECUTIVE PATIENTS TREATED FOR POSSIBLE INPH IN THE STUDY PERIOD. TWENTY-NINE (24.6 %) WERE EXCLUDED FROM THE STUDY BECAUSE THEY DID NOT MEET THE INCLUSION CRITERIA. THUS, THE FINAL SERIES CONSISTED OF 89 PARTICIPANTS (42 MEN AND 47 WOMEN) WITH A MEAN ± STANDARD DEVIATION AGE OF 72.5 ± 6.6. YEARS. ICP WAS MONITORED THROUGH A CODMAN MICROSENSOR ICP TRANSDUCER (JOHNSON & JOHNSON MEDICAL, (B)(4)). BOTH STATIC AND PULSATILE ICP WERE ANALYSED. ICP PULSATILITY WAS DETERMINED AS AN AVERAGE OF ALL OVERNIGHT WAVEFORMS. CLINICAL EVALUATION OF GAIT, COGNITION, AND INCONTINENCE WAS DONE PRE- AND 1 YEAR POST-SURGERY USING THE NORMAL PRESSURE HYDROCEPHALUS SCORE. SURGERY CONSISTS OF THE IMPLANTATION OF A VENTRICULO-PERITONITAL SHUNT. A CODMAN HAKIM PROGRAMMABLE VALVE (CODMAN & SHURTLEFF; (B)(4)) WAS PLACED. THE OPENING PRESSURE SETTINGS WERE SELECTED ON THE BASIS OF THE RESULTS OF THE MEAN ICP (AVERAGED OVERALL ICP MONITORING). THE MEDIAN OPENING PRESSURE AT SHUNT 11 CM H2O (RANGE, 3-20 CM H2O). SHUNT RESPONDERS WERE DEFINED AS PATIENTS WITH AN IMPROVEMENT OF ONE POINT OR MORE ON THE NPH SCORE AT 1 YEAR POST-SURGERY. ICP CATHETER COMPLICATIONS OCCURRED IN ONE PATIENT (1.1 %). WOUND INFECTION OCCURRED IN ONE PATIENT WITHOUT CLINICAL CONSEQUENCES. ONE YEAR AFTER SHUNTING, 64 PATIENTS (71.9 %) SHOWED CLINICAL IMPROVEMENT ACCORDING TO THE NPH SCORE. SIXTY-FOUR OF 89 PATIENTS CLINICALLY IMPROVED AT 1 YEAR POST-SURGERY AND WERE CLASSED AS SHUNT RESPONDERS. POSITIVE DESH FINDINGS HAD A SENSITIVITY OF 79.4 % AND SPECIFICITY OF 80.8 % FOR PREDICTING SHUNT RESPONDERS. FIFTY-FIVE OF 89 PATIENTS HAD POSITIVE DESH FINDINGS: 50 OF THESE RESPONDED TO VP SHUNT, GIVING A POSITIVE AND NEGATIVE PREDICTIVE VALUE OF 90.9 % AND 61.8 %, RESPECTIVELY. FIFTY-SEVEN OF 89 PATIENTS HAD HIGH ICP PULSE AMPLITUDE. HIGH ICP PULSE AMPLITUDE HAD A SENSITIVITY OF 84.4 %, SPECIFICITY OF 88 %, AND POSITIVE PREDICTIVE VALUE OF 94.7 % AND NEGATIVE PREDICTIVE VALUE OF 61.8 % FOR PREDICTING SHUNT RESPONDERS. IT WAS CONCLUDED BY THE AUTHORS THAT BOTH POSITIVE DESH FINDINGS AND HIGH ICP PULSE AMPLITUDE SUPPORT THE DIAGNOSIS OF INPH AND PROVIDE ADDITIONAL DIAGNOSTIC VALUE FOR PREDICTING SHUNT-RESPONSIVE PATIENTS; HOWEVER, HIGH ICP AMPLITUDE WAS MORE ACCURATE THAN POSITIVE DESH FINDINGS, ALTHOUGH IT IS AN INVASIVE TEST. BOTH GROUPS HAD COMPARABLE CARDIOVASCULAR RISK FACTORS. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850630 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention