FDA Adverse Event
Injury
Summary report: N
SETROX S 60
MDR report key: 1972254
·
Received January 21, 2011
Report
- Report Number
- 1028232-2011-00072
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- May 11, 2009
- Report Date
- January 11, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG,
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DISLODGMENT OF THIS LEAD TO THE TRICUSPID ANNULUS WAS NOTED. THE LEAD WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2009 AND ALL RECORDS INDICATE THIS LEAD REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 60 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG, | 350975 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |