FDA Adverse Event
Death
Summary report: N
SYNERGY
MDR report key: 1662678
·
Received April 16, 2010
Report
- Report Number
- 3004209178-2010-03097
- Event Type
- Death
- Date Received
- April 16, 2010
- Report Date
- March 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
THE PT EXPIRED AND THE CAUSE OF DEATH WAS UNK. THE HEALTHCARE PROVIDER CONFIRMED THAT THE EVENT WAS NOT ATTRIBUTED TO THE DEVICE. NO PT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | EXTENSION: MODEL 7489, LOT #NHU075173V| EXPLANTED| LEAD: MODEL 3999, LOT # V010133| EXTENSION: MODEL 7489, LOT # NHU075174V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: |