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

Catalog Number 82-3162

Device Problems Break (1069); Device Issue (2379)

Patient Problem No Information (3190)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

We could not get a "good" xray of the chpv to see what setting it was at.The clinician removed the valve and passed it to the tech and i could see that it was damaged internally.Occurred intra operatively; no delays.

Manufacturer 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 dismantled and was examined under microscope at appropriate magnification: a scratch mark in the valve casing was noted.This is probably due to the valve receiving some form of impact.The cam mechanism was also damaged.Corrosion was noted on the stator and the x ray dot.The cam magnets were controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3162, with lot cjcbrd, conformed to the specifications when released to stock on the 22nd may 2008.The root cause of the corrosion could not be clearly determined.The root cause for the dislodged stator and x ray dot could be partly due to the valve receiving some form of impact, as well as the corrosion, this however could not be determined.Investigation for the corrosion issue on hakim valves is being followed with capa.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 INLINE PROGRAMMABLE VALVE SG
• 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: 5289089
• MDR Text Key: 33271083
• Report Number: 1226348-2015-10746
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 82-3162
• Device Lot Number: CJCBRD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2008
• 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