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

Catalog Number 82-3192

Device Problems Device Issue (2379); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Numbers 510 (k): k061876 & k050739.(b)(6).Upon completion of the investigation a follow up report will be filed.

Event Description

Over the previous 2 weeks the programmer is consistently failing to recognize the reprogramming, necessitating an xray for verification.At present, xrays indicate the programmer is effectively changing to the desired pressure setting, however, the acoustic verification consistently fails to indicate that the shunt setting has been changed.Follow up received on 11-sep-2015.No outpatient consequences, but patients would have to be sent to xray for verification placing additional costs on hospital.Upon reps investigation, it was noted that the acoustic prong, located in the centre of programmer handpiece, is stuck in a depressed position, preventing it from coming in contact with patient skin.Over 5 instances between (b)(6) 2015.No specific dates provided.Rep will bring replacement device to account.

Manufacturer Narrative

The instrument was evaluated by the product manager and was found to be functioning properly.A review of manufacturing records was performed and no discrepancies were noted when the instrument was released to stock.The issue reported by the customer could not be reproduced.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: 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: 5104126
• MDR Text Key: 26755699
• Report Number: 1226348-2015-10557
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 82-3192
• Device Lot Number: CKLCD1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2009
• 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