FDA Adverse Event Injury Summary report: N

ROHS MICROSENSOR BASIC KIT

MDR report key: 7101377 · Received December 8, 2017

Report

Report Number: 1226348-2017-10971
Event Type: Injury
Date Received: December 8, 2017
Date of Event: November 16, 2017
Manufacturer: CODMAN & SHURTLEFF, INC.
Product Code: GWM
PMA / PMN Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

510K # OF SIMILAR PRODUCT CODE OF 826631: K914479. (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

THE SENSOR WAS RETURNED FOR EVALUATION. A REVIEW OF QUALITY RECORDS FOR THE COMPONENT FOUND THE SENSOR MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED COMPONENT FOUND NO VISIBLE DAMAGE TO THE SENSOR OR CONNECTOR. THE CATHETER MATERIAL WAS KINKED AT THE CONNECTOR AND THE STRAIN RELIEF WAS TORN. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THE EVALUATION THE ISSUE WAS UNABLE TO BE CONFIRMED. THE DEVICE FUNCTIONED AS INTENDED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem · 1

AS REPORTED BY THE OUS AFFILIATE, A DAY AFTER BEING IMPLANTED, A MICROSENSOR GAVE INCORRECT READINGS. IT WAS REVISED WITH ANOTHER MICROSENSOR THAT RECORDED ACCURATELY. NO TIME DELAYS WERE REPORTED AS THE IMPLANT AND EXPLANT OF THE SENSOR OCCURRED ON DIFFERENT DAYS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
879423	ROHS MICROSENSOR BASIC KIT	DEVICE, INTRACRANIAL PRESSURE MONITORING	GWM	CODMAN & SHURTLEFF, INC.		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention