Brand Name | VIVA XT CRT-P |
Type of Device | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
Manufacturer (Section D) |
IPG MFG SWITZERLAND |
route du molliau 31 |
tolochenaz 1131 |
CH 1131 |
|
Manufacturer (Section G) |
IPG MFG SWITZERLAND |
route du molliau 31 |
|
tolochenaz 1131 |
CH
1131
|
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 5712384 |
MDR Text Key | 47097051 |
Report Number | 9614453-2016-03803 |
Device Sequence Number | 1 |
Product Code |
NKE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/23/2016 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 08/14/2016 |
Device Model Number | C6TR01 |
Device Catalogue Number | C6TR01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/23/2016 |
Initial Date FDA Received | 06/09/2016 |
Supplement Dates Manufacturer Received | 03/23/2016
|
Supplement Dates FDA Received | 09/21/2017
|
Date Device Manufactured | 02/24/2015 |
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 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 84 YR |
|
|