MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH); SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS9008

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown part number, attempts to obtain product were unsuccessful, udi unavailable.It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, after 17 months, a valve separated and was revised.The valve was first implanted in (b)(6) 2017 with initial setting of 180mmh20.11 months later the patient complained about discomfort and his fore posture is getting worse.The ct scan showed that the lumber catheter had been separated and because the patient's condition was not critical, no immediate actions were taken.The revision procedure was done 7 months later with a setting of 150mmh20.The surgeon has requested a letter to show the possible reasons of the lumber catheter separation by the section.

Manufacturer Narrative

Udi (b)(4).Additional information -- the device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Udi: (b)(4).The device was returned for evaluation.The valve was visually inspected: silicone housing was damaged around the siphon guard, and the ends of the catheters appeared to be cut cleanly.A review of manufacturing records found the device conformed to specification when released to stock.Based on the results of the evaluation, the reported issue was confirmed.The root cause for the damage silicone house is likely due to a sharp or pointed object coming into contact with the silicone.The root cause for the catheter damage is likely due to a sharp or pointed object coming into contact with the silicone.As noted in the ifu silicone has a low cut/tear resistance.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH)
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8152487
• MDR Text Key: 130027083
• Report Number: 1226348-2018-10863
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: NS9008
• Device Lot Number: 109853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR