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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; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE, RT ANGLE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3184
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 06/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Upon completion of the investigation a follow up report will be filed.
 
Event Description
Shunt malfunction post implantations.
 
Manufacturer Narrative
It was not possible to investigate the complaint as no sample was returned for evaluation.Numerous attempts were made to recover the device, with no success.If the samples are returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the valve product code 82-3184 with lot cvlbn7, conformed to the specifications when released to stock on the 19th october 2016.A search for relative complaint for the bactiseal catheter was not possible as the lot number was unknown.The review of the dhr for the bactiseal catheter was not possible as the lot number give could not be found in our system.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.The device was subsequently provided.This report has been updated to reflect the corrected information.Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the images were taken of the ¿as received¿.The position of the cam when valve was received was 30 mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (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, only leak from the needle holes in the needle chamber was noted.The catheters were irrigated, no occlusions 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 82-3184, with lot cvlbn7, conformed to the specifications when released to stock in october 19th, 2016.Review of the history device records of product code 82-3072 with lot 1155727, was not performed as this lot number could not be found in our system.No root cause could be determined, as the problem reported by the customer could not be duplicated with the valve or the bactiseal catheters.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
Upon completion of the investigation it was noted that the images were taken of the ¿as received¿.The position of the cam when valve was received was 30 mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (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, only leak from the needle holes in the needle chamber was noted.The catheters were irrigated, no occlusions 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 82-3184, with lot cvlbn7, conformed to the specifications when released to stock in october 19th, 2016.Review of the history device records of product code 82-3072 with lot 1155727, was not performed as this lot number could not be found in our system.No root cause could be determined, as the problem reported by the customer could not be duplicated with the valve or the bactiseal catheters.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 Name
HAKIM PROGRAMMABLE VALVE, RT ANGLE
Type of Device
SHUNT, 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 Key6680190
MDR Text Key78788153
Report Number1226348-2017-10458
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,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Catalogue Number82-3184
Device Lot NumberCVLBN7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
82-3072
Patient Outcome(s) Required Intervention;
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