FDA Adverse Event
Malfunction
Summary report: N
PARADYM
MDR report key: 2211153
·
Received August 8, 2011
Report
- Report Number
- 1000165971-2011-00284
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- June 25, 2011
- Report Date
- July 26, 2011
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- MRM
- PMA / PMN Number
- P060027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2011. 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 (B)(6) 2011 F/U, THE PHYSICIAN OBSERVED THAT A WARNING RELATED TO A SUSPECTED ABNORMAL ATRIAL LEAD IMPEDANCE MEASURED ON (B)(6) 2011 WAS DISPLAYED TO THE USER. HOWEVER, ALL OTHER F/U DATA WERE NORMAL. THE PHYSICIAN ASKED FOR AN ANALYSIS OF THE REPORTED EVENT. DURING THE VF INDUCTION TEST, THE (B)(6) STAFF NOTICED THE PRESENCE OF BLUE NUMBERS BETWEEN THE "VS" MARKERS, IN THE EPS SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | MRM | SORIN BIOMEDICA CRM S.R.L. | PARADYM CRT 8750 | 2386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |