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U.S. Department of Health and Human Services

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

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3101
Device Problem Restricted Flow rate (1248)
Patient Problem Pain (1994)
Event Date 07/18/2018
Event Type  Injury  
Manufacturer Narrative
The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that a hakim valve was blocked after implantation and was revised. The valve was implanted to the patient; however, initial setting are unk. It was reported that the patient had a headache so the revision surgery was performed. The ventricular catheter was short, so the catheter's revision surgery was performed on (b)(6) 2018 (the valve was not revised). However, some damage of the valve was confirmed when the surgeon tried to change the pressure setting after the surgery, so the valve was revised. The sales force scheduled an interview the surgeon and will collect more detail. There was no surgical delay and there was no adverse consequence to the patient. No further information was provided by hospital. The products will be returned to your site. The patient¿s (b)(6) female. The surgeon commented that probably the valve got damaged when its pressure setting was change as its cam was came off.
 
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Brand NameHAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER
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 Key7785106
MDR Text Key117167933
Report Number1226348-2018-10580
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2010
Device Catalogue Number82-3101
Device Lot NumberCFLB0W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2018
Was Device Evaluated by Manufacturer? Yes
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: 08/15/2018 Patient Sequence Number: 1
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