FDA Adverse Event
Malfunction
Summary report: N
LUMAX 340 DR-T
MDR report key: 1150127
·
Received August 29, 2008
Report
- Report Number
- 1028232-2008-01069
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- July 7, 2008
- Report Date
- August 4, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PER THE OOS, THIS PT HAD SEVERAL SHOCKS AND CHARGES FOR THREE DAYS IN 2008. THIS DEVICE WAS OVERSENSING. THIS DEVICE WAS REPLACED WITH A COMPETITOR'S DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 DR-T | ICD | MRM | BIOTRONIK GMBH AND CO. | 355267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization |