FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/16
MDR report key: 1021846
·
Received March 28, 2008
Report
- Report Number
- 1028232-2008-00331
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- November 29, 2007
- Report Date
- March 3, 2008
- Manufacturer
- BIOTRONIK, INC.
- 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. NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS COULD BE FOUND THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. IN PARTICULAR, THE MEASUREMENT VALUE OF THE PACING IMPEDANCE WAS WITHIN THE LIMITS OF THE SPECIFICATION. THE ANALYSIS SHOWED NO INDICATIONS OF MFG ERRORS OR MATERIAL DEFECTS. BASED ON THE EXISTING ANALYSIS RESULTS, THE CLINICAL COMPLAINT WAS NOT DUE TO AN INAPPROPRIATE BEHAVIOR OF THE LEAD.
Description of Event or Problem · 1
A SHOCK DELIVERY DUE TO ARTIFACTS WAS REPORTED AFTER AN IMPLANTATION TIME OF 2 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK, INC. | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |