FDA Adverse Event
Death
Summary report: N
SIGMA 200 DR
MDR report key: 1882234
·
Received October 26, 2010
Report
- Report Number
- 2647346-2010-00698
- Event Type
- Death
- Date Received
- October 26, 2010
- Date of Event
- January 4, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIED. THE RELATEDNESS OF THE DEATH TO THE DEVICE SYSTEM WAS REPORTED AS "UNKNOWN". THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA 200 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | SDR203 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death |