Brand Name | MEDTRONIC EXTERNAL PACEMAKER |
Type of Device | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
Manufacturer (Section D) |
|
MDR Report Key | 14074317 |
MDR Text Key | 289190822 |
Report Number | MW5108861 |
Device Sequence Number | 1 |
Product Code |
DTE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
04/06/2022 |
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 | 5392 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/08/2022 |
Patient Sequence Number | 1 |
Patient Age | 59 YR |
Patient Sex | Male |
|
|