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

Catalog Number	823192R
Medical Device Problem Codes	Overheating of Device (1437); Output Problem (3005)
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
It was reported that the codman vpv programmer revised (823192r) incurred an "error: failure to set programming and overheat".It unknown under what circumstance this event occurred.No patient injury or surgical delay was reported.
Additional Manufacturer Narrative
The codman vpv programmer revised (823192r) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: the internal inspection did not confirm the reported issue.The programmer and transmitter were working properly; no error was found as per customer's report.Evaluation noted that if programming is performed on the high pressure then the head cooling error occurs; however, this is a normal error, and if the customer faces similar kind of error, then the transmitter has to be cooled down for 5-10 min and then the programming can be started again, as stated in instructions for use (ifu).Safety and functional tests were performed.Root cause analysis: the exact root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be "transmitter overheating".
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: 21133286
• Report Number: 3014334038-2024-00240
• Device Sequence Number: 7583175
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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
• Device Lot Number: 4090782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/11/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• 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