Brand Name | COMPIA MRI CRT-D |
Type of Device | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO |
Manufacturer (Section D) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
CH 1131 |
|
Manufacturer (Section G) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
CH
1131
|
|
Manufacturer Contact |
lisa
robertson
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635262723
|
|
MDR Report Key | 8195023 |
MDR Text Key | 131367254 |
Report Number | 9614453-2018-04538 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | P010031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/13/2019 |
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 |
Other
|
Device Expiration Date | 01/14/2019 |
Device Model Number | DTMC2D1 |
Device Catalogue Number | DTMC2D1 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/03/2019 |
Initial Date Manufacturer Received |
11/28/2018
|
Initial Date FDA Received | 12/26/2018 |
Supplement Dates Manufacturer Received | 02/06/2019
|
Supplement Dates FDA Received | 02/13/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/14/2017 |
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 |