MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR VPV PROGRAMMER PLUS TRANSMIT JPN; VPV SYSTEM

Catalog Number 823192

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the hakim programmer would not reprogram the valve or give confirmation.No patient injury/consequences reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g1, g3, g6, h2, h3, h4, h6, h10 the programmer was returned for evaluation.Device history record (dhr) - the lot history record for the device 82-3192, sn v01480 (lot # cfkbj9) was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock.Failure analysis - inspection confirmed the reported issue as error message displayed.Device has been reset, checked and functioned correctly.The root cause of the error message could occurred if the transmitter is disconnected during the self test or due to mains supply perturbation.

• Brand Name: VPV PROGRAMMER PLUS TRANSMIT JPN
• Type of Device: VPV SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10551035
• MDR Text Key: 207512540
• Report Number: 3013886523-2020-00115
• 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
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 823192
• Device Lot Number: V01480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1