FDA Adverse Event
Death
Summary report: N
DEEP BRAIN STIMULATION LEAD KIT
MDR report key: 1032802
·
Received April 23, 2008
Report
- Report Number
- 6000153-2008-02131
- Event Type
- Death
- Date Received
- April 23, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 25, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT SUFFERED A HEMORRHAGE AFTER STAGE 1 DEEP BRAIN STIMULATION IMPLANT. THE DEATH WAS REPORTED AS MULTIPLE SYSTEM FAILURE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD KIT | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3387S | V082506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |