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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE MICRO VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE MICRO VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3113
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 08/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Upon completion of the investigation, a follow up report will be filed.
 
Event Description
Customer reported rotor dislocated.Device revised (b)(6) 2017.
 
Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
(b)(4).The valve was returned for evaluation.The valve was visually inspected: stator and x-ray dot were dislodged of the baseplate, therefore; the cam position/pressure could not be determined.The valve was flushed and no occlusion was noted.The valve was leak tested; no leaks were found.The valve was reflux tested; the valve failed the test.The catheters were irrigated, with no occlusion or leakage noted.The valve was dismantled and was examined under microscope at appropriate magnification: stator and x-ray dot were dislodged of the base plate.Bumps mark were noted in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was also noted on the stator.The cam magnets were controlled and passed testing.The lot history record was reviewed for completeness during the release process to inventory.No discrepancies were noted for the products being accepted when released to stock.The stator dislodgement of chpv has been previously investigated.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.This issue will continue to be monitored through monthly complaint trending and the post market surveillance process.At present, we consider this complaint to be closed.
 
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Brand Name
HAKIM PROGRAMMABLE MICRO VALVE
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 Key6909061
MDR Text Key87989678
Report Number1226348-2017-10723
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053107
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2011
Device Catalogue Number82-3113
Device Lot NumberCGNB70
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/08/2017
Initial Date FDA Received10/02/2017
Supplement Dates Manufacturer Received10/10/2017
12/01/2017
Supplement Dates FDA Received10/16/2017
12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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