GDC 18 STANDARD SYNERG DETECTION CIRCUIT

Report

Report Number: 6000078-2006-00490
Event Type: Injury
Date Received: September 28, 2006
Report Date: August 21, 2006
Manufacturer: BOSTON SCIENTIFIC CORP. NEUROVASCULAR
Product Code: HCG
PMA / PMN Number: K991134
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT WAS IMPLANTED INTO THE PATIENT. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADD'L PMA/510 (K) #: K001083.

Description of Event or Problem · 1

THE PHYSICIAN REPORTED THE PATIENT SUFFERED A STROKE FOLLOWING THE TREATMENT OF AN ANEURYSM. IMAGING REVEALED A POSSIBLE INFLAMMATORY REACTION SURROUNDING THE TREATED ANEURYSM. THE PHYSICIAN REPORTED, HE WILL PROVIDE BOSTON SCIENTIFIC A FULL WRITTEN REPORT AND IMAGES FOR INVESTIGATION WHICH WILL INCLUDE THE PATIENT'S CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GDC 18 STANDARD SYNERG DETECTION CIRCUIT	DETACHABLE COIL	HCG	BOSTON SCIENTIFIC CORP. NEUROVASCULAR	350930-4	8004668

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention	MATRIX2 STANDARD 360 SR 7MM X 20CM\| MATRIX2 STANDARD 360 SR 8MM X 20CM\| GDC-18 2D 18MM X 30CM\| GDC-18 360 18MM X 40 CM\| GDC-18 360 20MM X 33CM\| GDC-18 360 20MM X 33CM\| MATRIX2 FIRM 360 20MM X 30CM\| GDC-18 360 22MM X 40CM\| MATRIX2 FIRM 360 24MM X 40CM\| MATRIX2 STANDARD 360 SR 10MM X 30CM\| MATRIX2 ULTRASOFT 360 SR 5MM X 15CM\| MATRIX2 SOFT 360 SR 7MM X 20CM\| GDC-10 STANDARD 8MM X 30CM\| MATRIX2 SOFT 360 SR 7MM X 20CM\| GDC-18 STANDARD 9MM X 30CM\| GDC-18 STANDARD 9MM X 30CM\| MATRIX2 STANDARD 360 SR 7MM X 20CM\| MATRIX2 SOFT 360 SR 8MM X 30CM\| MATRIX2 SOFT 360 SR 8MM X 30CM\| MATRIX 2 STANDARD 360 SR 8MM X 30CM\| MATRIX2 STANDARD 360 SR 9MM X 30CM\| MATRIX2 STANDARD 360 SR 8MM X 30CM\| MATRIX2 ULTRA SOFT 306 SR 4MM X 6CM\| MATRIX2 SOFT 360 SR 4MM X 8CM\| MATRIX2 SOFT 360 SR 8MM X 20CM\| MATRIX2 FIRM 360 18MM X 30CM\| GDC-18 2D 18MM X 30CM\| GDC-18 2D 12MM X 30CM\| GDC 18 360 12MM X 30CM\| GDC-18 2D 14MM X 30CM\| GDC-18 360 22MM X 40CM\| GDC-18 360 18MM X 40CM\| MATRIX2 STANDARD 360 SR 12MM X 30CM\| GDC-18 STANDARD 10MM X 30CM\| MATRIX2 ULTRA SOFT 360 SR 4 MM X 8CM\| MATRIX2 STANDARD 360 SR 7MM X 20CM\| GDC-18 2D 20MM X 30CM