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

Catalog Number 82-3192

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During shunt reprogramming, error message came up saying the transmitter is broken.As a result, patient has been admitted to the hospital while a vpv programmer is sourced from another hospital.Procedure has been re-scheduled on (b)(6) 2017.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of investigation, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the product was received in (b)(4) on march 21st, 2017.The product was tested in codman (b)(4) and it was reported that an error message displayed.The issue was confirmed.The device was forwarded to our supplier (b)(4): the investigation at the supplier detected that the front panel was damaged, the temperature sensor has not been verified and the attaché case was damaged.The front panel and the attaché case were replaced and the temperature sensor was verified.The device will be shipped back.As the issue was relating to a user error, no dhr review was performed for the vpv programmer 82-3192, sn (b)(4)(lot # cpmbk4).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: CODMAN VPV SYSTEM
• Type of Device: VALVE PROGRAMMER
• 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: 6419290
• MDR Text Key: 70408281
• Report Number: 1226348-2017-10173
• 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: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3192
• Device Lot Number: CPMBK4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2013
• 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