MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN MICROSENSOR BASIC KIT; ICP MICROSENSORS (3T)

Catalog Number 626631US

Device Problem No Device Output (1435)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/04/2021

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 a microsensor was implanted/tunneled on (b)(6) 2021 and worked for a day with icp of 14 and a good waveform.Then, after returning form a ct scan, the microsensor was not working.The ct did show good placement of the microsensor.The direct link module did not recognize the sensor.A customer tried resuming the direct link and using different icp monitors and nothing worked.They tried switching out cables and reconnecting and it did not resume.However, with a test sensor, the direct link worked fine.It was determined that the microsensor was damaged and it was replaced on (b)(6) 2021.

Manufacturer Narrative

The microsensor was returned for evaluation.Device history record (dhr) - the lot met specifications failure analysis - the issue of the complaint has been confirmed.Catheter stretched 26cm from connector.Internal wires are broken at stretched area.No testing possible.The root cause could be determined as a mishandling of the device.

Event Description

N/a.

• Brand Name: CODMAN MICROSENSOR BASIC KIT
• Type of Device: ICP MICROSENSORS (3T)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11578495
• MDR Text Key: 242676412
• Report Number: 3013886523-2021-00136
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K153347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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: 07/31/2022
• Device Catalogue Number: 626631US
• Device Lot Number: A308443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1