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 |
|
Manufacturer (Section G) |
GESPAC 18, CHEMIN DES AULX CH-1228 GEN¿VE SWITZLERLAND |
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 | 7340649 |
MDR Text Key | 102456572 |
Report Number | 1000165971-2018-00256 |
Device Sequence Number | 1 |
Product Code |
KRG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P980049 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
06/29/2018 |
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 |
Device Catalogue Number | ORCHESTRA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/09/2018 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 02/19/2018 |
Initial Date Manufacturer Received |
02/19/2018 |
Initial Date FDA Received | 03/15/2018 |
Supplement Dates Manufacturer Received | 06/21/2018
|
Supplement Dates FDA Received | 06/29/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|