FDA Adverse Event
Injury
Summary report: N
GDC 18-3D 3D-SHAPE SYNERG DETECTION CIRCUIT
MDR report key: 450823
·
Received March 27, 2003
Report
- Report Number
- 6000078-2003-00029
- Event Type
- Injury
- Date Received
- March 27, 2003
- Date of Event
- February 27, 2003
- Report Date
- March 27, 2003
- Manufacturer
- TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP.
- Product Code
- HCG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE PROCEDURE THE GDC 18-3D 3D-SHAPE SYNERG DETECTION CIRCUIT PREMATURELY DETACHED WITHOUT ANY POWER SUPPLY. THIS COIL WAS EASILY REMOVED. PT COMPLICATIONS REPORTED WERE PARESES OF THE RIGHT SIDE ARM, LEG, AND APHASIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 18-3D 3D-SHAPE SYNERG DETECTION CIRCUIT | DETACHABLE COIL | HCG | TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP. | * | 3975866 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Life Threatening| S | BRAND NAME: GUIDER XF 6F.| EXPIRATION DATE: 04/30/2004.| BRAND NAME: GDC 18-3D 3D-SHAPE SYNERG DETECTION| CIRCUIT. CATALOG#: 355203-4, LOT#: 3975866, |