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 |
|
MDR Report Key | 7689371 |
MDR Text Key | 114012963 |
Report Number | 1000165971-2018-00649 |
Device Sequence Number | 1 |
Product Code |
DXY
|
UDI-Device Identifier | 08031527011523 |
UDI-Public | (01)08031527011523(11)170627(17)181231 |
Combination Product (y/n) | N |
PMA/PMN Number | P950029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
07/20/2018 |
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 | 12/31/2018 |
Device Model Number | REPLY DR |
Device Catalogue Number | REPLY DR |
Device Lot Number | S0271 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 06/20/2018 |
Initial Date Manufacturer Received |
06/20/2018
|
Initial Date FDA Received | 07/16/2018 |
Supplement Dates Manufacturer Received | 07/16/2018
|
Supplement Dates FDA Received | 07/20/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|