Brand Name | COBALT¿ HF QUAD CRT-D MRI SURESCAN¿ |
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 |
SZ 1131 |
|
Manufacturer (Section G) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
SZ
1131
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 19000369 |
MDR Text Key | 338878743 |
Report Number | 9614453-2024-01258 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | PO |
PMA/PMN Number | P010031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/28/2023 |
Device Model Number | DTPB2QQ |
Device Catalogue Number | DTPB2QQ |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/25/2024 |
Date Device Manufactured | 01/06/2022 |
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 |
Treatment | 407652 LEAD, 459888 LEAD, 6935M62 LEAD. |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Sex | Male |