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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3842
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported by the affiliate that a codman hakim programmable valve became occluded and was revised. There were no reports of delay or patient harm. No further information was provided. The valve will be returned.
 
Manufacturer Narrative
Additional event information has been provided. This report has been updated to reflect the new information.
 
Event Description
It was reported by the affiliate that a codman hakim programmable valve became occluded and was revised. There were no reports of delay or patient harm. The valve was implanted after a cerebral tumorectomy on (b)(6) 2016 due to hydrocephalia. It was reported that the ventricular was not confirmed to be reducing on images during follow up, though it was not diagnosed as a clinical manifestation. In (b)(6) 2018, the patient was not feeling well and was crying. The pressure was checked by punctuating the reservoir, and the result showed that the pressure was quite high. The valve occlusion was suspected, and a revision surgery was performed on (b)(6) 2018. A new valve was implanted. The patient was recovering well.
 
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Brand NameHAKIM PROG VALVE INLINE SIPHONGUARD
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
MDR Report Key8143650
MDR Text Key129750723
Report Number1226348-2018-10854
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K992173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number82-3842
Device Lot NumberCVFCVL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
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