MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE INLINE UNIT (INTEGRAL CON); SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3844

Device Problem Programming Issue (3014)

Patient Problems Neurological Deficit/Dysfunction (1982); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the ous sales rep, chpv inline valves w/o siphonguard changed their setting after patients left the hospital.There were no reports of delay or patient harm.

Manufacturer Narrative

Updated udi: (b)(4).It was initially reported that the device would be returned for evaluation.It was later communicated that the device would not be returned.Additional event information was received from the initial reporter.This report has been updated to reflect the updated information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.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

As reported by the ous sales rep, chpv inline valves w/o siphonguard had unexpected setting changes after implantation.The patient had symptoms with this event and the valve needed to be reprogrammed.

• Brand Name: HAKIM VALVE INLINE UNIT (INTEGRAL CON)
• 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: 7292604
• MDR Text Key: 100843766
• Report Number: 1226348-2018-10179
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 82-3844
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention