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

Model Number	823192R
Medical Device Problem Code	Overheating of Device (1437)
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
A facility reported a codman vpv programmer was overheating when attempting reading for patient¿s hakim valve.No additional information available.
Additional Manufacturer Narrative
The programmer was returned for evaluation: dhr - lot met specifications when released.Failure analysis - fault confirmed.The transmitter cover is cracked and must be replaced, along with the attached switch and dome plug.While testing the transmitter, it did eventually overheat.However, this was after ten adjustments, which is a normal number a transmitter operating in cool ambient temperature.Transmitter cover, switch and dome plug have been replaced.Repair performed with reset, safety, and functional test.The possible root cause of the defective device could be due to a bad handling from the user.

• Brand Name: CODMAN VPV PROGRAMMER REVISED
• Common Device Name: VPV SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14167038
• Report Number: 3013886523-2022-00181
• Device Sequence Number: 14708670
• Product Code: JXG
• UDI-Device Identifier: 10886704078609
• UDI-Public: 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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 Model Number: 823192R
• Device Catalogue Number: 823192R
• Device Lot Number: 133030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2017
• 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