FDA Adverse Event
Injury
Summary report: N
LINOX SMART PROMRI SD 65/16
MDR report key: 3193439
·
Received June 27, 2013
Report
- Report Number
- 1028232-2013-01783
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- April 5, 2013
- Report Date
- June 13, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVY
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE, BASED ON THE EXISTING MANUFACTURING DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE HAS BEEN EXAMINED. THE PRODUCTION DOCUMENTS SHOWED NO ABNORMALITIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE PERFORMED CORRECTLY. IN SUMMARY, NO EVIDENCE EXISTS TO A MANUFACTURING ERROR.
Description of Event or Problem · 1
OUS MDR - THIS RV LEAD WAS FOUND TO BE DISLODGED. ALSO, LOSS OF SENSING WAS NOTED. A REVISION PROCEDURE WAS PERFORMED. ALL AVAILABLE INFORMATION SUGGESTS THIS LEAD REMAINS IMPLANTED. THE DATE OF IMPLANT WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291660 | LINOX SMART PROMRI SD 65/16 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 377169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |