FDA Adverse Event
Injury
Summary report: N
ELOX EX 53-BP
MDR report key: 1101223
·
Received August 5, 2008
Report
- Report Number
- 1028232-2008-00826
- Event Type
- Injury
- Date Received
- August 5, 2008
- Date of Event
- June 25, 2008
- Report Date
- July 3, 2008
- Manufacturer
- BIOTRONIK, GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- K994240
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PER MDRF, THIS SYSTEM WAS REMOVED DUE TO INFECTION. THIS LEAD WAS REPLACED WITH A COMPETITOR'S LEAD. THE EXPLANTED SYSTEM: LUMAX 340 DR-T, MDR: 1028232-2008-00824; KAINOX SL 65/16, MDR: 1028232-2008-00825; ELOX EX 53-BP, MDR: 1028232-2008-00826.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELOX EX 53-BP | PACER LEAD | DTB | BIOTRONIK, GMBH AND CO. | 130018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization |