Brand Name | REPLY |
Type of Device | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) |
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 | 6335923 |
MDR Text Key | 67932268 |
Report Number | 1000165971-2017-00120 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 08031527014173 |
UDI-Public | (01)08031527014173(11)150902(17)170402 |
Combination Product (y/n) | N |
Reporter Country Code | SZ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/24/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/02/2017 |
Device Model Number | REPLY CRT-P |
Device Catalogue Number | REPLY CRT-P |
Device Lot Number | S0113 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 01/24/2017 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
01/24/2017 |
Initial Date FDA Received | 02/16/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/02/2015 |
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 |