FDA Adverse Event
Injury
Summary report: N
6000025-1999-00003
MDR report key: 266031
·
Received November 12, 1999
Report
- Report Number
- 6000025-1999-00003
- Event Type
- Injury
- Date Received
- November 12, 1999
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
ARTICLE EVALUATED 126 PATIENTS UNDER CONTROLLED SITUATION (VF THERAPY PROGRAMMED "OFF") WITH EXTREME EXPOSURE TIME TO SURVEILLACE SYSTEMS. AUTHOR REPORTS CONTINUOUS NOISE W/GATE EXPOSURE INTERPRETED BY ICD AS VF (N=1) . ALSO REPORTED DELAY IN PACING (N=4) AND PACING INHIBITION (N=1) .
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 000 | Other |