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 Problems Device Dislodged or Dislocated (2923); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

Udi: gtin unavailable, product made prior to compliance date upon completion of the investigation a follow up report will be filed.

Event Description

The device was implanted via v-p shunt to a patient with snph in 2009.The initial pressure setting was 100mm h2o.When checking the device by contrast radiography because no clinical effects were obtained, the patency was not confirmed.The surgeon tried to change the setting, but it could not be changed.Therefore, the device was replaced on (b)(6) 2016.The setting of the removed valve was 100mm h2o.The patient's condition is good after the revision.According to the surgeon, the cam appeared to be dislodged when checking the removed valve.

Manufacturer Narrative

Updated udi: gtin unavailable, product made prior to compliance date; (b)(4).Device evaluation: model/lot #, device available for evaluation?, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, device manufacture date, evaluation codes, additional mfr narrative.Upon completion of the investigation it was noted that the valve was visually inspected it was noted that the stator and x ray dot were dislodged.Therefore; the cam position/pressure could not be determined.The valve was hydrated for 24 hours.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: corrosion was noted on the stator and the x ray dot.Review of the history device records confirmed the valve product code 82-3100, with lot cjlbyz, conformed to the specifications when released to stock on the 8th october 2008.The root cause of the dislodged stator and x ray dot could be due to corrosion, this however could not be determined.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.

• 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; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5930538
• MDR Text Key: 53988545
• Report Number: 1226348-2016-10635
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 82-3100
• Device Lot Number: CJLBYZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2008
• 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