MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNI-SHUNT WITH RESERVOIR KIT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8532

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Unishunt faulty.Dr had to use another unishunt 78 cm, patient (b)(6).

Manufacturer Narrative

It was not possible to investigate the complaint as no sample was returned for evaluation.If the sample is returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the valve product code 82-8532, with lot cvfbfw, conformed to the specifications when released to stock on the 28th april 2016.No root cause could be determined as the sample was not returned for investigation.If the sample is returned in the future, this complaint will be re-opened and the sample investigated.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.A follow-up report will be submitted when the device has been evaluated.

Manufacturer Narrative

Upon completion of the investigation it was noted that the images were taken of the device ¿as received¿.A slight bend in the rod was noted.The shunt was returned in an opened box.A tear was noted at one end of the box, this is probably happened when opening the box.No creases or bend marks noted with the box.No creases or bend marks noted with the plastic tray or lid.A search for relative complaint for the same issue with the same product code and lot number for the last year revealed that this is the only issue.Review of the history device records for the device product code 82-8532, with lot cvfbfw, conformed to the specifications when released to stock on the 28th april 2016.The root cause of the problem found during investigation could not be determined, per investigation the device was released to stock conformed, as the packaging was opened it is not possible to determine when the rod was bent.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: UNI-SHUNT WITH RESERVOIR KIT
• 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: 6323516
• MDR Text Key: 67162745
• Report Number: 1226348-2017-10097
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 82-8532
• Device Lot Number: CVFBFW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO