FDA Adverse Event
Injury
Summary report: N
GDC COILS
MDR report key: 1001951
·
Received February 20, 2008
Report
- Report Number
- 2939204-2008-00049
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- December 4, 2007
- Report Date
- January 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED WIDE NECK ANEURYSM AT THE TIP OF THE BASILAR ARTERY. AN UNDISCLOSED NUMBER OF GDC COILS [SUBJECT OF THIS REPORT] WERE USED TO EMBOLIZE THE ANEURYSM WITHOUT ADJUNCTIVE STENTING OR BALLOON REMODELING. POST PROCEDURE, THE PATIENT WAS REPORTED TO HAVE "AGNOSIA, SLURRED SPEECH, BLURRED VISION AND HEADACHES" AND WAS TREATED WITH MEDICATION AND HOSPITALIZATION. THE OUTCOME WAS REPORTED AS "RESOLVED WITH NO RESIDUAL EFFECTS" AND A CT SCAN WAS ALSO COMPLETED. THE PHYSICIAN ATTRIBUTED TO THE SYMPTOMS TO "MIGRAINES AND ANXIETY AND POSSIBLY TO THE DEVICE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC COILS | (HCG) DETACHABLE COIL | HCG | BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other | BOSTON SCIENTIFIC GDC COILS| NUMBER AND MODELS UNKNOWN |