FDA Adverse Event
Other
Summary report: N
LUMOS DR-T
MDR report key: 2257210
·
Received September 14, 2011
Report
- Report Number
- 1028232-2011-02147
- Event Type
- Other
- Date Received
- September 14, 2011
- Report Date
- August 30, 2011
- Manufacturer
- BIOTRONIK SE 7 CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS EXPLANTED SOME TIME IN 2010. THE ASSOCIATED REPRESENTATIVE WAS NOT PRESENT AT THE DEVICE EXTRACTION AND HAS NO ADDITIONAL INFORMATION. THE FOLLOWING PHYSICIAN'S OFFICE WILL NOT RETURN PHONE CALLS. THE DATE AND REASON OF EXTRACTION ARE UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMOS DR-T | ICD | LWS | BIOTRONIK SE 7 CO. KG | 353220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |