Brand Name | PARADYM RF |
Type of Device | DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) |
Manufacturer (Section D) |
SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
parc d'affaires noveos 4 avenue réaumur |
. |
clamart 92140 |
FR 92140 |
|
Manufacturer (Section G) |
SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY |
parc d'affaires noveos 4 avenue réaumur |
. |
clamart 92140 |
FR
92140
|
|
Manufacturer Contact |
elodie
vincent
|
parc d'affaires noveos 4 avenue réaumur |
. |
clamart 92140
|
FR
92140
|
0146013665
|
|
MDR Report Key | 6486311 |
MDR Text Key | 72790137 |
Report Number | 1000165971-2017-00304 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | PO |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/14/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/12/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2015 |
Device Model Number | PARADYM RF SONR CRT-D 9770 |
Device Catalogue Number | PARADYM RF SONR CRT-D 9770 |
Device Lot Number | 2813 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 03/14/2017 |
Date Manufacturer Received | 07/04/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/31/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|