FDA Adverse Event
Injury
Summary report: N
LINOX SMART SD 60/16
MDR report key: 3092004
·
Received May 3, 2013
Report
- Report Number
- 1028232-2013-01306
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 24, 2012
- Report Date
- April 22, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVY
- PMA / PMN Number
- P980023
- 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, ELECTRICAL AND MECHANICAL 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 WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193921 | LINOX SMART SD 60/16 | ICD LEAD | NVY | BIOTRONIK SE & CO. KG | 359065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization |