FDA Adverse Event
Malfunction
Summary report: N
LINOX SD 65/16
MDR report key: 1122173
·
Received August 15, 2008
Report
- Report Number
- 1028232-2008-00917
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- February 26, 2008
- Report Date
- July 21, 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
OUS MDR. THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS WERE FOUND THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE STRETCHING OF THE SHOCK COILS IS PROBABLY DUE TO EXCESSIVE MECHANICAL STRESS DURING THE EXPLANATION. THE ANALYSIS DID NOT INDICATE ANY MANUFACTURING ERRORS OR MATERIAL DEFECTS.
Description of Event or Problem · 1
OUS MDR. INAPPROPRIATE VF DETECTIONS WERE REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 4 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX SD 65/16 | ICD LEAD | LWS | BIOTRONIK, GMBH AND CO. | 350053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |