FDA Adverse Event
Other
Summary report: N
LINOX SD 65/16
MDR report key: 2083086
·
Received April 29, 2011
Report
- Report Number
- 1028232-2011-00980
- Event Type
- Other
- Date Received
- April 29, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 19, 2011
- Manufacturer
- BIOTRONIK SE & 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 RV LEAD DISLODGED. TACHYCARDIA DETECTION WAS DISABLED AND A LEAD REVISION HAS BEEN SCHEDULED FOR (B)(6) 2011. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK SE & CO. KG | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |