MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CODMAN VPV SYSTEM; VALVE PROGRAMMER

Catalog Number 82-3192

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

Patient Problem No Information (3190)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Both 510(k) #'s for this product code: k061876 & k050739.Upon completion of the investigation, a follow up report will be filed.

Event Description

Elsg tage report vpv valve programmer repair of unit description of failure: as before - programmer sometimes the valve programs then says programming failed and try again, however it is setting the valve but sometimes it fails.Patient has to go for x- ray to confirm.Device error message: no other information available.When was the problem discovered?: pre-operatively.Surgical delay?: none.

Manufacturer Narrative

It has been discovered that the report associated with this event is a duplicate of that filed under mdr 26348-2016-10680.Please refer to that report for information regarding the reported event.

• Brand Name: CODMAN VPV SYSTEM
• Type of Device: VALVE PROGRAMMER
• 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: 5992689
• MDR Text Key: 56096921
• Report Number: 1226348-2016-10697
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention