Brand Name | CAPSUREFIX NOVUS LEAD MRI SURESCAN |
Type of Device | PERMANENT PACEMAKER ELECTRODE |
Manufacturer (Section D) |
MEDTRONIC SINGAPORE OPERATIONS |
49 changi south avenue 2 |
nasaco tech centre |
singapore 48605 6 |
SN 486056 |
|
Manufacturer (Section G) |
MEDTRONIC SINGAPORE OPERATIONS |
49 changi south avenue 2 |
nasaco tech centre |
singapore 48605 6 |
SN
486056
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 19151091 |
MDR Text Key | 340675913 |
Report Number | 3008973940-2024-02859 |
Device Sequence Number | 1 |
Product Code |
DTB
|
UDI-Device Identifier | 00681490124799 |
UDI-Public | 00681490124799 |
Combination Product (y/n) | Y |
Reporter Country Code | JA |
PMA/PMN Number | P930039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/22/2024 |
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 Model Number | 5076-45 |
Device Catalogue Number | 5076-45 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/16/2024
|
Initial Date FDA Received | 04/22/2024 |
Date Device Manufactured | 01/11/2024 |
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 | W2DR01 IPG, 5076-52, LEAD. |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|