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

Catalog Number NS9008

Device Problem Programming Issue (3014)

Patient Problem Headache (1880)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

The valve was implanted to the patient via lp-shunt on (b)(6) 2017 with setting was 70mmh2o due to normal pressure hydrocephalus.The patient complained a headache.It was reported that the pressures setting was not able to be changed when the surgeon tried to change the setting.Therefore the surgeon tried to change it by neodymium and it could be changed.However the pressures setting was not able to be changed again after that.The removal surgery was performed on (b)(6) 2018.The patient was (b)(6) female.Csf protein: unknown.It was suspected of blood and debris contamination in the cerebrospinal fluid.No further information was provided by the hospital.The product will not be returned to your site.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated udi : (b)(4).The device was returned for evaluation.The valve was visually inspected; a small cut/tear was noted in the silicone housing over the valve casing and needle holes in the needle chamber, no biological debris was noted.The position of the cam when valve was received was 70mmh2o.The valve was tested for programming.The valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed; no occlusion was noted.The valve was leak tested; only leaked from the needle holes in the needle chamber, did not leak from the small cut/tear in the silicone housing.The catheters were irrigated, no occlusions noted.The valve was reflux tested and passed.The siphon guard was tested and passed.The siphon guard was removed and the valve was pressure tested; the valve passed.The cam mechanism was moved with a needle, no resistance was noted.The valve was program tested and failed; the cam did not move.The cam magnets were controlled and failed testing.The magnets polarity was controlled and failed; all magnets were on (+).Review of the device history records for the valve found the device conformed to specification when released to stock.The root cause for the cut/tear in the silicone housing is due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu silicone has a low tear and cut resistance.The root cause for the programming problem is due to the cam magnets.The abnormal polarization of the valve was likely caused by exposure to too strong magnetic field.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM 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
• MDR Report Key: 7278559
• MDR Text Key: 100390233
• Report Number: 1226348-2018-10168
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: NS9008
• Device Lot Number: CTJBBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR