FDA Adverse Event
Injury
Summary report: N
DBS
MDR report key: 2803178
·
Received January 26, 2006
Report
- Report Number
- 2649622-2006-01731
- Event Type
- Injury
- Date Received
- January 26, 2006
- Date of Event
- December 12, 2005
- Report Date
- December 30, 2005
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
HCP REPORTED A PT IN THE (B)(6) STUDY EXPERIENCED CONFUSION, PSYCHOSIS, AND HALLUCINATIONS. A CT SCAN WAS PERFORMED, WHICH SHOWED NO CHANGE. CAROTID ULTRASOUND SHOWED NO SIGNIFICANT STENOSIS. EDG SHOWED A JUNCTIONAL RHYTHM. THE PT WAS TREATED WITH MEDICATION CHANGES AND FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DBS | LEAD | LGW | MEDTRONIC PUERTO RICO OPERATIONS | 3387 | J0421511V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL: 7482, LOT # NHU052091V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL: 7482, LOT # NHU051646V| LOT # NFD100326H| IMPLANTABLE NEURO STIMULATOR: MODEL: 7428,| IMPLANTED:| IMPLANTED: |