Brand Name | PLATINIUM |
Type of Device | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION |
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 |
laura
ouaki
|
parc d'affaires noveos 4 avenue réaumur |
. |
clamart 92140
|
FR
92140
|
146013429
|
|
MDR Report Key | 9961854 |
MDR Text Key | 188207120 |
Report Number | 1000165971-2020-00356 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 08031527014425 |
UDI-Public | (01)08031527014425(11)170912(17)190412 |
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 |
Report Date |
04/15/2020 |
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 | 04/12/2019 |
Device Model Number | PLATINIUM SONR CRT-D 1841 |
Device Catalogue Number | PLATINIUM SONR CRT-D 1841 |
Device Lot Number | S0280 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 04/06/2020 |
Initial Date Manufacturer Received |
04/06/2020
|
Initial Date FDA Received | 04/15/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/12/2017 |
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 |