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

Catalog Number 82-3190

Device Problems Device Displays Incorrect Message (2591); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When the surgeon tried to change the pressure setting with the programmer, an error message was displayed and the programmer could not reprogram the setting.As a result, the patient needs to re-visit the hospital and have the setting reprogrammed later.

Manufacturer Narrative

Additional information: it was initially reported that the device would be returned for evaluation.It was later communicated that the device would not be returned.This report has been updated to reflect this corrected information complaint sample was not returned to codman; therefore, the evaluation could not be performed.The cause(s) of the difficulty reported by the customer could not be determined.A dhr review was performed for the programmer 82-3190, s/n: (b)(4) (lot# cndbtl), and the lot met specifications when released on march 14th, 2012.If the device is returned in the future, the complaint will be reopened and a follow-up report will be submitted.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN HAKIM PROGRAMMER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5781977
• MDR Text Key: 49153658
• Report Number: 1226348-2016-10492
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3190
• Device Lot Number: CNDBTL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• 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