MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE; CHPV

Model Number 82-3834

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nausea (1970)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

The hakim valve was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

A nurse reported a hakim valve was implanted to a patient on (b)(6) 2021.The patient had nausea symptoms and may require their chpv valve to be adjusted.The nausea symptoms presented around the time of patient's secondary surgery on (b)(6) 2021 for a revision of c6-7 fusion and the closure of the dura from a csf leak.The shunt was originally set at 160mmhg and adjusted 24 hours post op to 120mmhg.The shunt was then adjusted to 140mmhg on (b)(6) 2021.The patient still have nausea symptoms.

• Brand Name: PROG VALVE INLINE
• Type of Device: CHPV
• 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: 12523971
• MDR Text Key: 273108055
• Report Number: 3013886523-2021-00406
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704041832
• UDI-Public: (01)10886704041832(17)250331(10)4610227
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 82-3834
• Device Catalogue Number: 823834
• Device Lot Number: 4610227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/23/2021
• Date Device Manufactured: 04/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1