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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNKNOWN HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3XXX
Device Problem Insufficient Information (3190)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Type  Injury  
Manufacturer Narrative
Complaint sample was not returned to codman and no 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.
 
Event Description
As reported to codman via it's web site: it was reported that after implantation of an unknown hakim valve, the patient experienced headaches and vomiting. When the patient got on a monorail, a headache, described as tightening in the head, occurred and then the patient vomited. The patient pumped the valve a few times, and was able to sleep that day. On another occasion, while riding in a car, with the subwoofer at the front center or the dvd player built-in at headrest, the patient again experienced the tightening in the head type headache. The patient is taking care not to be close to the speakers while riding in a car, and is requesting information regarding the effect of magnetic fields on the device, such as is listed in the ifu. The device remains implanted, thus unavailable for analysis.
 
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Brand NameUNKNOWN HAKIM VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle, CH240 0
SZ CH2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
le locle, CH240 0
SZ CH2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key7740884
MDR Text Key115764235
Report Number1226348-2018-10548
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number82-3XXX
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 Received07/10/2018
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: 08/01/2018 Patient Sequence Number: 1
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