FDA Adverse Event
Injury
Summary report: N
SELOX JT 53
MDR report key: 3211816
·
Received July 8, 2013
Report
- Report Number
- 1028232-2013-01835
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 15, 2013
- Report Date
- June 28, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT, THE LEAD WAS SUBJECTED TO A FUNCTIONAL ANALYSIS. THE PERFORMANCE OF THE DEVICE UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. DURING THIS ANALYSIS, NO DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE LEAD PROVED TO BE WITHIN SPECIFICATIONS AND FLAWLESS THROUGHOUT ITS INSPECTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.
Description of Event or Problem · 1
THIS LEAD BECAME DISLODGED AND WAS REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309002 | SELOX JT 53 | PACER LEAD | NVN | BIOTRONIK SE & CO. KG | 346368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization |