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

Catalog Number	823192R
Medical Device Problem Codes	Device Emits Odor (1425); Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
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 by the facility's outpatient department that the codman vpv programmer revised (823192r) "did not turn off then crackled and smelt of electrical burning." it is unknown under what circumstance this event occurred; however, no injury, death or surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: d4 (lot#), d9, g3, g6, h2, h3, h4, h6, h11.Corrected field: d4 (udi#).The loaner/codman vpv programmer revised (823192r) was returned from the customer facility: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: internal inspection of the codman vpv programmer did not confirm the reported issue.The report of the smell of smoke was not confirmed.Unrelated to the reported complaint, the insulation of one foot was noted to be damaged due to misuse.The foot required replacement.Repair was performed with reset, safety, and functional tests.Root cause analysis: the exact root cause of the issue reported by customer could not be determined as the device worked correctly.However, a possible root cause of the defect reported by the customer could be excessive power to coils.

• 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: 20997797
• Report Number: 3014334038-2024-00231
• Device Sequence Number: 6678097
• Product Code: JXG
• UDI-Device Identifier: 10886704078609
• UDI-Public: 10886704078609
• 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): 03/26/2025

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: 105575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 12/22/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2016
• 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