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

Catalog Number NS9008

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Complaint sample was not returned to codman and no 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.

Event Description

It was reported that separation of a lumber catheter of the hakim programmable valve occurred and the catheter remained behind in the backbone arachnoidal lower cavity.The valve was implanted to the patient; however, date of implant and initial setting are unknown.Therefore, the surgeon hesitate about a judgment what he/she should have been going to do.The surgeon requested an offer of documents about the remaining to a backbone arachnoidal lower cavity or data about the deficient incidence about the separation of lumbar catheter.Ic and vp-shunt will perform after the surgeon receive the information.Additionally, the surgeon commented that shunt failure occurred by separation of the lumber catheter, and the symptom is slightly got worse.The symptoms included ventricular enlargement and difficulty walking.No further information was provided by hospital.The product will not be returned to your site.

• Brand Name: CODMAN HAKIM PROGRAMMABLE 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
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 5088282726
• MDR Report Key: 7781356
• MDR Text Key: 117129713
• Report Number: 1226348-2018-10567
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NS9008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other