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); Corroded (1131); Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that breakage was found when performing the removal surgery on (b)(6).No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Event Description

As reported by the affiliate, a valve was revised as it was suspected of being broken.The product will be returned to your site.

Manufacturer Narrative

The event description has been updated based on additional information received from the initial reporter.

Manufacturer Narrative

The device was returned for evaluation.The valve was visually inspected it was noted that the stator was dislodged as well as a crack in the valve casing and a cut/tear in the silicone housing.The valve was dismantled and was examined under microscope at appropriate magnification: a crack was noted in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was also noted on the stator.The cam magnets were controlled and passed testing.Review of the device history records confirmed the product conformed to the specifications when released to stock.The root cause for the cut/tear in the silicone housing could be due to the valve receiving a hard knock or a sharp or pointed object coming into contact with the valve, as noted in the ifu silicone has a low cut /tear resistance.The root causes for the dislodged stator could be partly due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.The stator dislodgement of chpv has been previously investigated.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.Trends will be monitored for these and similar complaints.At present, we consider this complaint to be 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; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7273013
• MDR Text Key: 100148372
• Report Number: 1226348-2018-10144
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 82-3100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 02/13/2018; 03/13/2018; 04/16/2018
• Supplement Dates FDA Received: 02/26/2018; 03/28/2018; 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention