FDA Adverse Event
Malfunction
Summary report: N
2183613-1999-00012
MDR report key: 265483
·
Received September 8, 1999
Report
- Report Number
- 2183613-1999-00012
- Event Type
- Malfunction
- Date Received
- September 8, 1999
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE IN STANDBY MODE, DEVICE WENT TO ABLATION MODE. NO PATIENT COMPLICATIONS REPORTED.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 000 | Other |