FDA Adverse Event Injury Summary report: N

CODMAN MICROSENSOR BASIC KIT

MDR report key: 11120727 · Received January 5, 2021

Report

Report Number: 3013886523-2020-00296
Event Type: Injury
Date Received: January 5, 2021
Date of Event: December 14, 2020
Report Date: March 3, 2021
Manufacturer: INTEGRA LIFESCIENCES SWITZERLAND SAR
Product Code: GWM
PMA / PMN Number: K153347
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE MICROSENSOR WAS RETURNED FOR EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS: LOT NUMBER 4800435, 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. SUTURE AND TAPE ATTACHED TO CATHETER MATERIAL. DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. ICP EXPRESS PASSED WITH READING OF 522. 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.

Additional Manufacturer Narrative · 1

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A PHYSICIAN REPORTED THE MICROSENSOR ICP READING WAS 18 WHEN IT WAS IMPLANTED, AFTER A FEW MINUTES, THE ICP READING WENT UP TO 28 WITH VALUES FROM HIGH TO LOW. THE ISSUE WAS NOTED WHEN THE SENSOR WAS PLACED IN THE PARENCHYMA. A NEW SENSOR WAS OPENED AND PLACED (SAME LOT NUMBER) AND THE PATIENT'S ICP WAS 8 AND WORKED WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
15559	CODMAN MICROSENSOR BASIC KIT	ICP MICROSENSORS (3T)	GWM	INTEGRA LIFESCIENCES SWITZERLAND SAR		4800435

Patients

Seq	Age	Sex	Outcome	Treatment
1