Brand Name | CARELINK SMARTSYNC |
Type of Device | ANALYZER, PACEMAKER GENERATOR FUNCTION |
Manufacturer (Section D) |
PLEXUS MANUFACTURING SDN. BHD |
bayan lepas free industrial zo |
bayan lepas 11900 |
MY 11900 |
|
Manufacturer (Section G) |
PLEXUS MANUFACTURING SDN. BHD |
bayan lepas free industrial zo |
|
bayan lepas 11900 |
MY
11900
|
|
Manufacturer Contact |
lisa
robertson
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635262723
|
|
MDR Report Key | 8483164 |
MDR Text Key | 140919864 |
Report Number | 3004593495-2019-00299 |
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,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/14/2019 |
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 |
Health Professional
|
Device Model Number | 24970A |
Device Catalogue Number | 24970A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/11/2019 |
Initial Date FDA Received | 04/04/2019 |
Supplement Dates Manufacturer Received | 05/10/2019
|
Supplement Dates FDA Received | 05/14/2019
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |