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

Catalog Number 82-3184

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

As reported by the ous affiliate, a programmable valve and bactiseal catheter failed to reprogram to work surgery.There were no reports of delay or patient harm.Was the valve and catheter revised?- "replacement provided.".

Manufacturer Narrative

(b)(4).A review of manufacturing records was performed and found no discrepancies when the device was released to stock.If additional relevant information is provided in the future, the complaint will be reopened and a follow-up report will be submitted.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE, RT ANGLE
• 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7086898
• MDR Text Key: 94235547
• Report Number: 1226348-2017-10925
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 82-3184
• Device Lot Number: CVHB2W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• 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