FDA Adverse Event
Malfunction
Summary report: N
3004753838-2019-022477
MDR report key: 8381917
·
Received March 1, 2019
Report
- Report Number
- 3004753838-2019-022477
- Event Type
- Malfunction
- Date Received
- March 1, 2019
- Date of Event
- January 31, 2019
- Report Date
- February 15, 2019
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PT REPORTS TRANSMITTER NOT FOUND.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |