MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Catalog Number 826631

Device Problem No Device Output (1435)

Patient Problem Injury (2348)

Event Date 11/26/2020

Event Type  Injury  

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 that on (b)(6) 2020 a microsensor was connected with the icp monitor and no readings were showing on the monitor and the microsensor was not able to be zeroed.The device problem occurs during the procedure before implantation and an approximately 30 minute delay was reported.

Manufacturer Narrative

Updated fields: d4, d10,g1, g4, g7,h2, h3, h4, h6, h10.Unique device identifier (udi) : (b)(4).The microsensor was returned for evaluation: review of the history device records for the product code 82-6631 with lot 4154796 conformed to the specifications when released to stock.Failure analysis - based on the analysis and investigation, the issue of the complaint has not been confirmed.No visible damage to the millar sensor, catheter material, or connector.Device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to excessive pressure applied to product.

Event Description

N/a.

• Brand Name: NEUROMONITOR BASIC KIT
• Type of Device: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11042072
• MDR Text Key: 222677515
• Report Number: 3013886523-2020-00259
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 826631
• Device Lot Number: 4154796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1