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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNKNOWN HAKIM PRECISION VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNKNOWN HAKIM PRECISION VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number UNK HAKIM PRECISION VALVE
Device Problem Restricted Flow rate (1248)
Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Hydrocephalus (3272)
Event Date 05/10/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
In the literature article ¿diagnosis, classification, and management of fourth ventriculomegaly in adults: report of 9 cases and literature review¿ by kaveh barami, indro chakrabarti, james silverthorn, jeremy ciporen, and paul t. Akins. , published world neurosurg. (2018) 116:e709-e722. Https://doi. Org/10. 1016/j. Wneu. 2018. 05. 073 it was reported that after implantation, the hakim fixed pressure valve had underdrainage with neurologic symptoms, cardiac arrhythmias and nausea/vomiting and the device was revised. Per the article: ¿ an enlarged fourth ventricle, otherwise known as fourth ventriculomegaly (4th vm), has been reported previously in the pediatric population, yet literature on adults is scant. We report our experience with 4th vm in adults over an 11-year period and review the literature. ¿ this is a (b)(6) year-old male who presented with nausea & vomiting and a 30 pound weight loss. He was diagnosed with 4th ventriculomegaly and treated with external drainage later converted to an unknown codman hakim 100-mm pressure valve. Seven months after implantation, the patient presented with nausea & vomiting accompanied by headache. The diagnosis was mild hydrocephalus of the lateral and third ventricles with disproportionate enlargement of the 4th ventricle. Again external drainage was initiated with resolution of symptoms; however, when weaning from external drainage, the patient developed neurogenic cardiac arrhythmias, atrial fibrillation. External drainage was reinstated successfully, and was eventually weaned and a codman hakim programmable valve was successfully implanted. At the time of complaint entry, no device specific information, i. E. Catalogue/lot number, is available. This article was identified in the monthly review.
 
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Brand NameUNKNOWN HAKIM PRECISION VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7822687
MDR Text Key118526069
Report Number1226348-2018-10620
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HAKIM PRECISION VALVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/28/2018 Patient Sequence Number: 1
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