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 Break (1069); Device Dislodged or Dislocated (2923); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

Udi: gtin unavailable, product made prior to compliance date; (b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The valve cannot be adjusted anymore after an mr.Defect of valve: setting disc shows broken axle and dislocation.

Manufacturer Narrative

Corrected udi: gtin unavailable, product made prior to compliance date; ((b)(4).Upon completion of the investigation it was noted that the valve was visually inspected it was noted that the stator was 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 catheter was irrigated, no occlusion was noted.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and a scratch mark were noted in the valve casing.This is probably due to the valve receiving some form of impact.Corrosion was noted on the stator.The cam magnets were controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3100, with lot cmjbv2, conformed to the specifications when released to stock on the 5th august 2011.The root cause of the corrosion could not be clearly determined.The root causes for the dislodged stator could be partly due to the valve receiving some form of impact, as well as the 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: 6114615
• MDR Text Key: 60415540
• Report Number: 1226348-2016-10789
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 82-3100
• Device Lot Number: CMJBV2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2011
• 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