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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 Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 11/16/2016
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation a follow up report will be filed.
 
Event Description
The device was implanted via v-p shunt to a patient with hydrocephalus after subarachnoid hemorrhage on (b)(6) 2016. The first setting was 80mmh2o. In the rehabilitation hospital after the operation, the rehabilitation doctor found the patient was suspected to have shunt malfunction, and the patient was transferred to (b)(6). The ventricle of brain was not reduced according to image. The valve was replaced to 82-3110 on (b)(6) 2016. Setting was 80mm h2o. The patient is (b)(6).
 
Manufacturer Narrative
Updated udi: gtin unavailable; (b)(4). Device evaluation: model #/lot #, device available for evaluation?, date received by mfr?, type of reports, if follow-up, what type?, device evaluated by mfr?, device manufacture date, evaluation codes, additional mfr narrative. Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve. The valve was visually inspected: no defects were noted. The position of the cam when valve was received was 70 mm h2o. The valve was hydrated for 24 hours. The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test. The valve was flushed, the valve passed the test no occlusion was noted. The valve was leak tested, no leaks were noted. The valve was reflux tested, the valve passed the test. The valve was dried. The valve was then pressure tested, the valve passed the test. Review of the history device records confirmed the valve product code 82-3101 with lot ctpbcn, conformed to the specifications when released to stock in 13th january 2016. No root cause could be determined, as the problem reported by the customer could not be duplicated. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
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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 case postale
le locle
SZ
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6142459
MDR Text Key61358557
Report Number1226348-2016-10840
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number82-3101
Device Lot NumberCTPBCN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
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: 12/02/2016 Patient Sequence Number: 1
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