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

Catalog Number 823192R

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

A facility reported a vpv programmer wasn¿t receiving confirmations and it was overheating after using multiple times.No patient injury reported and it is unknown if the event led to surgical delay.

Manufacturer Narrative

The codman programmer (id 823192r) was returned for evaluation.Device history record (dhr): the product 823192r for serial number (b)(6) (lot # 4042694), and the lot met specifications when released failure analysis: the inspection in integra usa has no reported error message issue.Device has been reset, checked and returned to customer.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 to a technical problem of the system or to programmer/transmitter malfunction, valve malfunction.

Event Description

N/a.

• Brand Name: CODMAN VPV PROGRAMMER REVISED
• Type of Device: 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: 12512803
• MDR Text Key: 272694084
• Report Number: 3013886523-2021-00401
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K061876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 823192R
• Device Lot Number: 4042694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1