FDA Adverse Event
Malfunction
Summary report: N
REPLY
MDR report key: 6127006
·
Received November 24, 2016
Report
- Report Number
- 1000165971-2016-00753
- Event Type
- Malfunction
- Date Received
- November 24, 2016
- Date of Event
- March 13, 2016
- Report Date
- October 26, 2016
- Manufacturer
- SORIN GROUP ITALIA S.R.L. - CRM FACILITY
- Product Code
- MRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON A SCHEDULED FOLLOW-UP, ONE EPISODE OF VENTRICULAR BURST WAS VERIFIED THAT ACTUALLY IS NOISE ON THE VENTRICULAR OR ATRIAL LEAD. DURING THE FOLLOW-UP, IT WAS ASKED TO THE PATIENT TO PERFORM SOME MANEUVERS TO EXCLUDE OR CONFIRM MYOPOTENTIALS, BUT THE NOISE WAS NOT REPRODUCED. WE WANT TO KNOW THE POSSIBLE SOURCE OF THE NOISE.
Description of Event or Problem · 1
ON A SCHEDULED FOLLOW-UP, ONE EPISODE OF VENTRICULAR BURST WAS VERIFIED THAT ACTUALLY IS NOISE ON THE VENTRICULAR OR ATRIAL LEAD. DURING THE FOLLOW-UP, IT WAS ASKED TO THE PATIENT TO PERFORM SOME MANEUVERS TO EXCLUDE OR CONFIRM MYOPOTENTIALS, BUT THE NOISE WAS NOT REPRODUCED. WE WANT TO KNOW THE POSSIBLE SOURCE OF THE NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777496 | REPLY | MRM | SORIN GROUP ITALIA S.R.L. - CRM FACILITY | REPLY D | 2533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |