FDA Adverse Event
Malfunction
Summary report: N
OVATIO
MDR report key: 2782096
·
Received October 5, 2012
Report
- Report Number
- 9610579-2012-00096
- Event Type
- Malfunction
- Date Received
- October 5, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 14, 2012
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
REPORTEDLY, DURING A VALVE REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2012, VT INDUCTION AND ATP DELIVERY FEATURES IN EPS SCREEN WERE USED TO TRY TO PACE THE HEART AT 200 MIN-1 DURING 8 SECONDS. HOWEVER, THE MARKER CHANNEL WAS DISPLAYED WITHOUT ANY MARKERS VISUALIZED. AN EXPLANATION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVATIO | MRM | SORIN CRM | OVATIO DR 6550 | M090206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |