FDA Adverse Event
Malfunction
Summary report: N
PARADYM
MDR report key: 1881155
·
Received October 1, 2010
Report
- Report Number
- 1000165971-2010-00915
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 9, 2010
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE INITIAL DEVICE INTERROGATION DURING SCHEDULED FOLLOW-UP (ON (B)(6) 2010) WAS INTERRUPTED AND SOME ERROR MESSAGE(S) RELATED TO COMMUNICATION PROBLEM WAS/WERE DISPLAYED. HOWEVER, A SECOND INTERROGATION COULD BE PERFORMED SUCCESSFULLY; NEVERTHELESS, NO DATA WAS AVAILABLE IN THE DEVICE'S MEMORIES ((B)(4)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | MRM | SORIN BIOMEDICA CRM S.R.L. | PARADYM CRT 8750 | 2366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |