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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number NS9008
Device Problem Restricted Flow rate (1248)
Patient Problem No Information (3190)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 the hakim programmable valve was occluded after implantation causing underdrainage and revision of the device. The hakim valve was implanted to the patient via lp shunt; however, date of implant and initial setting are unknown. Post operatively, it was determined that the valve was not draining properly, therefore, the patient went to another facility/physician for second opinion. Without removal of the complaint hakim valve, a second valve (polaris by sophysa) was implanted, also via vp shunt. Later, the patient returned to the initial facility/physician, where it was decided that the hakim valve was unnecessary; therefore, it was removed. It was noted that a brown material was in the valve and contributed to the drainage dysfunction. No further information was provided by hospital. The products will be returned to your site.
 
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Brand NameHAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH)
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key7886854
MDR Text Key120693131
Report Number1226348-2018-10658
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNS9008
Device Lot Number127546
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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