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

Catalog Number 82-3100

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Udi: product made prior to compliance date, gtin unavailable.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 vp-shunt about 15 years ago.Doi and initial setting were unknown.It was reported that the surgeon tried to changing the pressure setting but it was not able to be changed.The revision surgery was performed on (b)(6) 2017.The patient is female but her age is unknown.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The product will not be returned to your site.

Manufacturer Narrative

It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was incorrectly reported in additional mfr narrative that the device had not been made available for evaluation.The device has been returned and will be evaluated.Upon completion of the investigation a follow-up report will be submitted.

Manufacturer Narrative

Updated udi: product made prior to compliance date, gtin unavailable; (b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected; it was noted that the x ray dot was dislodged and sitting on the cam mechanism as well as the outlet spring is no longer sitting correctly.The position of the cam when valve was received was 80 mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4) and programmer 82-3190 with serial (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed, the valve passed the test.The valve was leak tested, no leaks noted.The valve was reflux tested, the valve passed the test.The valve was dried.The valve was pressure tested at 80 mmh2o, the valve passed the test.The valve was dismantled and was examined under microscope at appropriate magnification: a crack in the valve casing was noted.Biological debris was found on the spring, on the spring pillar, and on the base plate.The cam magnets were also controlled.The magnets passed.The lot history record was reviewed for completeness during the release process to inventory.At that time, based on the fact that no discrepancies were noted for the products being accepted, they were released to stock in 2002.The root cause for the crack in the valve casing was probably due to the valve receiving some form of impact, this however could not be determined.The root cause for the outlet spring, is probably due to the valve receiving some form of impact but this could not be determined.The root cause for the dislodged x ray dot was probably due to the valve receiving some form of impact as well as corrosion, this however could not be determined.The root cause of the programming problem is due to the biological debris found on the spring, on the spring pillar, and on the base plate.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

A previous report incorrectly listed the lot number.The lot number was not provided and not able to be obtained.This report has been updated to reflect the corrected information.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
• 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 Key: 7151757
• MDR Text Key: 95951049
• Report Number: 1226348-2017-11007
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• 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 Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3100
• Device Lot Number: PT6611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention