Brand Name | CARELINK SMARTSYNC PLATFORM (IOS) |
Type of Device | ANALYZER, PACEMAKER GENERATOR FUNCTION |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street ne |
mounds view MN 55112 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
8200 coral sea street ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 10400955 |
MDR Text Key | 202701495 |
Report Number | 2182208-2020-01507 |
Device Sequence Number | 1 |
Product Code |
DTC
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | P890003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
11/04/2020 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 08/13/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | M01A01 |
Device Catalogue Number | M01A01 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/09/2020 |
Was Device Evaluated By Manufacturer? |
No Answer Provided
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient TREATMENT DATA |
Date Received: 08/13/2020 Patient Sequence Number: 1 |
Treatment |
PROGRAMMER 24970A |
|
|
|