FDA Adverse Event
Summary report: N
SELOX SR 60
MDR report key: 3060812
·
Received April 16, 2013
Report
- Report Number
- 1028232-2013-00636
- Date Received
- April 16, 2013
- Date of Event
- March 20, 2012
- Report Date
- February 19, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.
Description of Event or Problem · 1
THE LEAD WAS CAPPED AND REPLACED DUE TO "OVERSENSING ON V LEAD WITH UNDERSENSING OF R WAVES". SHOULD ADD'L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162566 | SELOX SR 60 | PACER LEAD, PRODUCT CODE: NVN | NVN | BIOTRONIK SE & CO. KG | 343082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Hospitalization |