FDA Adverse Event
Malfunction
Summary report: N
LINOX S 75
MDR report key: 1021850
·
Received March 28, 2008
Report
- Report Number
- 1028232-2008-00389
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- December 17, 2007
- Report Date
- February 29, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. IN REGARD TO THE ELECTRICAL PROPERTIES OF THE LEAD, NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS COULD BE FOUND THAT COULD BE RELATED TO THE CLINICAL OBSERVATION. NO MFG ERROR OR MATERIAL DEFECT COULD BE FOUND DURING THE ANALYSIS.
Description of Event or Problem · 1
SEVERAL INAPPROPRIATE VF DETECTIONS WITH A SHOCK DELIVERY WERE REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 4 WEEKS. THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX S 75 | ICD LEAD | LWS | BIOTRONIK GMBH AND CO. | 351334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |