FDA Adverse Event
Death
Summary report: N
EVIA DR-T
MDR report key: 2172054
·
Received July 13, 2011
Report
- Report Number
- 1028232-2011-01515
- Event Type
- Death
- Date Received
- July 13, 2011
- Date of Event
- June 13, 2011
- Report Date
- July 4, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUS MDR.
Description of Event or Problem · 1
OUS MDR - THE PATIENT HAD A HISTORY OF MYOCARDIAL INFARCTION AND COMPLETE AV BLOCK WITH NO INTRINSIC RATE. (B)(6) 2011, ATRIAL OVERDRIVE PACING WAS ACTIVATED DURING THE PATIENT FOLLOW-UP. (B)(6) THE PATIENT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVIA DR-T | PACEMAKER | NVZ | BIOTRONIK SE & CO. KG | 359529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |