MAUDE Adverse Event Report: CSF VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 07/31/2006

Event Type  Injury  

Manufacturer Narrative

It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

In the literature search ¿case report: programmable shunt-related suicide attempt¿ published acta neurochir (wien) (2006) 148: 1307¿1310, doi 10.1007/s00701-006-0850-1, it was reported that a (b)(6) male attempted suicide by alcohol, medications and self-adjustment of his programmable csf valve.Per the article: ¿the treatment of hydrocephalus has benefited recently from the use of programmable shunt valves.These devices can be adjusted using magnets to regulate how much spinal fluid is drained.However, it is unclear to what extent other environmental magnetic sources can affect programmable valves.We present the case of a man who attempted suicide by successfully turning his adjustable valve to a near-maximal setting using a hand-held electromagnet, and discuss other reported cases in order to better understand the effects of environmental magnets on programmable shunt valves¿.A head ct was performed emergently and showed marked ventriculomegaly when compared to his previous study.In addition, a plain film was obtained to evaluate his valve setting, which was found to be at a near-maximal setting of 190mm of water.The patient¿s shunt was tapped, his valve was turned down to 120mm, and he was admitted for observation.Because his shunt appeared to be functioning properly, we spared him another surgery to interrogate and revise the shunt or convert it to a third ventriculostomy.By the next morning, his mental status had improved and, after psychiatric evaluation, he was discharged to his family¿s care.¿ at the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: CSF VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6041496
• MDR Text Key: 57872157
• Report Number: 1226348-2016-10735
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• 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): Required Intervention
• Patient Age: 54 YR