FDA Adverse Event
Injury
Summary report: N
SELOX JT 45
MDR report key: 3173917
·
Received June 17, 2013
Report
- Report Number
- 1028232-2013-01718
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- May 15, 2013
- Report Date
- June 5, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
THIS LEAD WAS CAPPED AND REPLACED FOR AN UNKNOWN REASON. ATTEMPTED TO FIND OUT MORE INFORMATION, BUT NO ADDITIONAL INFORMATION WAS RECEIVED. THERE WERE NO KNOWN PATIENT EVENTS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273692 | SELOX JT 45 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 346369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization |