Type of Device | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
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 |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7951433 |
MDR Text Key | 123219470 |
Report Number | 3004593495-2018-00973 |
Device Sequence Number | 1 |
Product Code |
DTE
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K150246 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
10/31/2018 |
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 |
Device Catalogue Number | 5392 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/12/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/06/2018 |
Initial Date FDA Received | 10/10/2018 |
Supplement Dates Manufacturer Received | 10/30/2018 10/31/2018
|
Supplement Dates FDA Received | 10/30/2018 10/31/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | Z-1356-2015 |
Patient Sequence Number | 1 |