FDA Adverse Event
Injury
Summary report: N
SETROX S 45
MDR report key: 2070313
·
Received April 18, 2011
Report
- Report Number
- 1028232-2011-00828
- Event Type
- Injury
- Date Received
- April 18, 2011
- Date of Event
- March 16, 2011
- Report Date
- April 4, 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
THIS LEAD EXPLANTED DIRECTLY AFTER BEING IMPLANTED BECAUSE THE LEAD DROPPED A FEW TIMES. AFTER THE POCKET WAS CLOSED, THE PHYSICIAN REALIZED THIS HAD HAPPENED AGAIN AND HAD TO RE-OPEN THE POCKET AND REPLACED THE LEAD WITH A COMPETITOR'S LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 45 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG | 350973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization |