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

Model Number	82-6631
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Hydrocephalus (3272)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The microsensor was not returned for evaluation (discarded) 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 or Problem Description
A facility reported a patient was sent to the hospital due to an aneurysm rupture and subarachnoid hemorrhage.Then the physician conducted the paraventriculostomy with medtronic external ventricular drainage system and icp microsensor implantation with the codman microsensor on (b)(6) 2020.After the procedure, the patient got infection treated with antibiotics and secondary hydrocephalus.The cause of the infection was not confirmed and the type of organism is unknown.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12708326
• Report Number: 3013886523-2021-00450
• Device Sequence Number: 3984062
• Product Code: GWM
• UDI-Device Identifier: 20886704042317
• UDI-Public: 20886704042317
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 82-6631
• Device Catalogue Number: 826631
• Device Lot Number: 3711852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1