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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, RT ANGLE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3182
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 03/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
Shunt implanted and found not working.
 
Manufacturer Narrative
It was not possible to investigate the complaint as no sample was returned for evaluation. If the sample is returned in the future, this complaint will be re-opened and evaluated. A search for relative complaint for the same issue was not possible as the lot numbers were unknown for both devices. Review of the history device records for the valve was not possible as the lot number was unknown. Review of the history device records for the bactiseal catheter was not possible as the lot number was unknown. 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. Device not available.
 
Manufacturer Narrative
(b)(4). It was previously reported that the device would not be returned. Subsequently the device was provided for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation, it was noted that the images were taken of the valve ¿as received¿. The valve was visually inspected; no defects noted. The position of the cam when valve was received was 70mmh2o. The valve was hydrated. 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 noted. The catheters were irrigated, no occlusions were noted. The valve was reflux tested. The valve passed the test. The siphon guard was tested. The valve passed the test. The valve was dried. The siphon guard was removed. The valve was then pressure tested, the valve passed the test. Review of the history device records confirmed the valve product code 82-3115, with lot cplcb1, conformed to the specifications when released to stock on the 21st october 2013. Review of the history device records for the catheter was not possible at the lot number was unknown. 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.
 
Manufacturer Narrative
It was previously reported that the device would not be returned. Subsequently, the device was provided for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
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Brand NameHAKIM PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD
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 Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6538678
MDR Text Key74228086
Report Number1226348-2017-10300
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992173
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,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number82-3182
Device Lot NumberCPLCB1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2013
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: 05/02/2017 Patient Sequence Number: 1
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