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

Catalog Number	823192R
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the codman vpv programmer revised (823192r) was smoking.It is unknown under what circumstance this event occurred; however, no injury, death or surgical delay was reported.
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.
Additional Manufacturer Narrative
A review of our complaint management system has determined that an initial mdr was already submitted for this event under mfg report# 3014334038-2024-00231.Thus, mfg report# 3014334038-2024-00231 and 3014334038-2024-00238 are duplicates - reports of the same event.As a result, this record pr 341732/mfg report# 3014334038-2024-00238 will be inactive and complaint linked to pr 340302/mfg report# 3014334038-2024-00231 will remain as the respective complaint/report.A follow-up report will be submitted related to 3014334038-2024-00231 once investigation results become available.
Event or Problem Description
N/a.

• 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 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21095172
• Report Number: 3014334038-2024-00238
• Device Sequence Number: 8657140
• Product Code: JXG
• UDI-Device Identifier: 10381780538325
• UDI-Public: 10381780538325
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: Other
• Device Catalogue Number: 823192R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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