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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

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 no longer detectable.The microsensor was placed on a male patient on (b)(6) 2021 for the treatment of a traumatic injury.On (b)(6) 2021 the patient was taken from neuro icu to ct scan and when the patient returned to the neuro icu room the sensor was no longer detectable.The representative went to icu with the doctor to troubleshoot with various cables and monitors.When a new microsensor was placed on the same monitors it was being detected.It was determined that microsensor was no longer working.The physician removed the microsensor.

Manufacturer Narrative

The microsensor was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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.

• 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: 11579336
• MDR Text Key: 242686382
• Report Number: 3013886523-2021-00140
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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 Catalogue Number: 626631US
• Device Lot Number: A316036
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 05/21/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1