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

Catalog Number 823192

Device Problems Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978); Excessive Heating (4030)

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

Event Date 06/10/2020

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 reports that their hakim programmer is broken.When trying to program a patient¿s implanted valve the programmer over heats and is unsuccessful in programming.

Event Description

N/a.

Manufacturer Narrative

The hakim programmer was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.Failure analysis - the internal inspection has verified the reported issue: transmitter head has cracks and no testing could be performed.The root cause of the issue reported by customer could be due to bad handling from user and as the device was manufactured in 2009, we can also consider that this issue was due to normal wear out.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 10221642
• MDR Text Key: 198711612
• Report Number: 1226348-2020-00348
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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: CKKBRZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2009
• 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