FDA Adverse Event
Malfunction
Summary report: N
LINOX S 65
MDR report key: 1872459
·
Received October 8, 2010
Report
- Report Number
- 1028232-2010-02074
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- August 10, 2010
- Report Date
- September 7, 2010
- Manufacturer
- BIOTRONIK SE & CO KG
- Product Code
- LWS
- PMA / PMN Number
- P980023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.
Description of Event or Problem · 1
RV OVERSENSING WAS REPORTED TO US. THE IMPLANTATION DATE WAS NOT MENTIONED. THE LEAD WAS EXPLANTED, BUT NOT RETURNED. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINOX S 65 | ICD LEAD | LWS | BIOTRONIK SE & CO KG | 351333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |