FDA Adverse Event
Malfunction
Summary report: N
SELOX ST 53
MDR report key: 2101935
·
Received May 17, 2011
Report
- Report Number
- 1028232-2011-01122
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 9, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS LEAD HAD A POSSIBLE FRACTURE. THE PHYSICIAN ATTEMPTED TO REPLACE THIS LEAD BUT WAS UNSUCCESSFUL DUE TO STENOSIS. THE PT WAS REFERRED TO A CV SURGEON THE NEXT DAY TO HAVE THIS LEAD EXTRACTED AND A NEW RV LEAD IMPLANTED. THIS LEAD WAS RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFO BECOME AVAILABLE THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELOX ST 53 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG | 346366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |