Brand Name | REPLY |
Type of Device | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
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 | 7087538 |
MDR Text Key | 93873825 |
Report Number | 1000165971-2017-00908 |
Device Sequence Number | 1 |
Product Code |
DXY
|
UDI-Device Identifier | 08031527009032 |
UDI-Public | (01)08031527009032(11)170215(17)180915 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P950029 |
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 |
11/10/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/15/2018 |
Device Model Number | ESPRIT DR |
Device Catalogue Number | ESPRIT DR |
Device Lot Number | S0249 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/15/2017 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 11/10/2017 |
Initial Date Manufacturer Received |
11/10/2017
|
Initial Date FDA Received | 12/06/2017 |
Supplement Dates Manufacturer Received | 12/14/2017
|
Supplement Dates FDA Received | 01/10/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/15/2017 |
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;
|