FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 2043269
·
Received February 25, 2011
Report
- Report Number
- 1000165971-2011-00083
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 25, 2011
- Report Date
- February 4, 2011
- Manufacturer
- SORIN C.R.M., S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT ON (B)(6) 2011, WHEN HE PROGRAMMED THE SMOOTHING FEATURE TO SLOW AND THE AUTO-THRESHOLD TO ON, HE OBSERVED THAT THE SMOOTHING WAS MODIFIED FROM SLOW TO MEDIUM. THE PHYSICIAN ASKED FOR AN EXPLANATION OF THE REPORTED EVENT. PRELIMINARY ANALYSIS HAVE SHOWN THAT THIS BEHAVIOR IS A PROGRAMMING CONSTRAINT DESCRIBED IN THE ONLINE HELP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN C.R.M., S.R.L. | REPLY SR | 2483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |