MICROTARGETING ELECTRODE

Report

Report Number: 3005677147-2010-00001
Event Type: Injury
Date Received: March 5, 2010
Date of Event: February 9, 2010
Report Date: February 12, 2010
Manufacturer: FHC, INC.
Product Code: GZL
PMA / PMN Number: K991522
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

F/U WITH DISTRIBUTOR REP NOTED "THERE WAS NO INDICATION THAT THE BLEEDING CAME FROM A MISUSE OR BROKEN INSERTION CANULE AND/OR THE MICROELECTRODES. ALL MICROELECTRODES WERE INTACT WHEN RETRACTED FROM THE BRAIN AND ALSO THE INSERTION CANULES SEEMED TO BE OK - NO BENDING AND/OR MICRO TIPS BROKEN." EVAL OF THE PRODUCT WAS NOT POSSIBLE AS THEY WERE DISCARDED AFTER THE SURGERY. THERE IS NO INDICATION THAT THE PRODUCTS WERE AT FAULT IN THIS INCIDENT.

Description of Event or Problem · 1

DISTRIBUTOR REPRESENTATIVE REPORTED ABNORMAL PT RESPONSE AFTER RECORDING AND DURING STIMULATION WITH THE SECOND ELECTRODE, IN THE RIGHT HEMISPHERE, WHICH WAS 1.5MM ABOVE INTENDED TARGET. LEFT HEMISPHERE PROCEDURE HAD BEEN COMPLETED WITHOUT INCIDENT. SPEECH OF PT WAS LOW AND INCOMPREHENSIBLE AND WITH A SUDDEN RISE IN BLOOD PRESSURE. FURTHER TESTING BY NEUROLOGIST GAVE NO CONCLUSIVE EVIDENCE ON STATUS OF PT, THOUGH MOVEMENT ON BOTH SIDES OF THE BODY WAS UNEVEN. DBS ELECTRODE WAS IMPLANTED AND PT WAS TAKEN FOR CT SCAN. BLEEDING WAS SHOWN IN THE RIGHT HEMISPHERE, STARTING AT LEAST 1CM ABOVE THE TIP OF THE DBS ELECTRODE DIAGONAL TOWARDS FRONT AND UPWARDS AND PARTIALLY ALONG ELECTRODE TRAJECTORY. AT THE TIME OF INCIDENT REPORT, PT HAD A PARTIAL HEMIPARESIS ON THE LEFT SIDE. F/U FINDS THAT PT REMAINS HEMIPLEGIC, CONSCIOUS AND HAS DIFFICULTIES TO SPEAK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MICROTARGETING ELECTRODE		GZL	FHC, INC.		8773523

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Disability	FC1018 ARRAY ELECTRODE INSERTION TUBE SET