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

Catalog Number 826631

Device Problem Mechanical Problem (1384)

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

Event Date 09/15/2020

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 reported the microsensor could not be zeroed.The event occurred before the procedure, the physician changed with another of the same device which could be zeroed normally.No surgical delay and no adverse consequences for the patient.

Manufacturer Narrative

Updated fields: d4, d10, g4, g7,h2, h3, h4, h6, h10.Unique device identifier: (b)(4).The neuromonitor basic kit was not returned for evaluation (device not returned yet - no shipping information provided) 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

N/a.

Manufacturer Narrative

The perforator was returned for evaluation.Device history record (dhr) - lot 4170957, conformed to the specifications when released to stock.Failure analysis - complaint has been confirmed.No visible damage to the millar sensor, catheter material or connector.The icp express failed, zeroing error.The millar sensor could not be zeroed upon receipt; tried to adjust balance and still could not be zeroed; sensor ohms are spec.The cause of the problem stated to be use related, the sensor ohms are in spec, but the balance cannot be adjsuted.This anomaly could possibly be attributed to esd (electrostatic discharge) exposure.

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: 10610758
• MDR Text Key: 209356761
• Report Number: 3013886523-2020-00140
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826631
• Device Lot Number: 4170957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1