Brand Name | ORCHESTRA |
Type of Device | PROGRAMMER, PACEMAKER |
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 | 8915519 |
MDR Text Key | 155233188 |
Report Number | 1000165971-2019-00491 |
Device Sequence Number | 1 |
Product Code |
MRM
|
Combination Product (y/n) | N |
PMA/PMN Number | P980049 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Type of Report
| Initial,Followup |
Report Date |
10/31/2019 |
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 Model Number | ORCHESTRA PLUS |
Device Catalogue Number | ORCHESTRA PLUS |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/09/2019 |
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 07/29/2019 |
Event Location |
Outpatient Diagnostic Facility
|
Initial Date Manufacturer Received |
07/29/2019
|
Initial Date FDA Received | 08/21/2019 |
Supplement Dates Manufacturer Received | 10/09/2019
|
Supplement Dates FDA Received | 10/31/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|