MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN VPV PROGRAMMER REVISED; VPV SYSTEM

Catalog Number	823192R
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
1 of 4 reports.Other mfg report numbers: 3013886523-2024-00021, 3013886523-2024-00022, 3013886523-2024-00023.A facility reported: "we are finding that most times when we try to program a valve, the machine will tell us adjustment incomplete multiple times.However, when we have sent patients for xr to check the status anyway, on numerous occasions we have found that the valve has actually adjusted - but the machine said it hadn't." "multiple patients have had to attend for x-rays on 3-6 occasions.¿.
Additional Manufacturer Narrative
Programmer was returned for evaluation: dhr - lot cvhb5t sn (b)(6), conformed to the specifications when released to stock failure analysis - the inspection did not confirm the reported issue.The full functional test, reset and safety test according to manufacturer¿s specification have been performed.Root cause - the root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause for this issue reported by the customer could be due a technical problem of the system.

• Brand Name: CODMAN VPV PROGRAMMER REVISED
• Common Device Name: VPV SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18624168
• Report Number: 3013886523-2024-00020
• Device Sequence Number: 12612000
• Product Code: JXG
• UDI-Device Identifier: 10886704078609
• UDI-Public: (01)10886704078609
• Combination Product (Y/N): N
• PMA/510(K) Number: K061876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823192R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown