Brand Name | KAPPA 900 DR |
Type of Device | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE |
Manufacturer (Section D) |
MDT PUERTO RICO OPERATIONS CO, MED REL |
road 909, km. 0.4., barrio mar |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT PUERTO RICO OPERATIONS CO, MED REL |
road 909, km. 0.4., barrio mar |
|
humacao PR 00792 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7255421 |
MDR Text Key | 99837713 |
Report Number | 2647346-2018-00004 |
Device Sequence Number | 1 |
Product Code |
DXY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P980035 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/08/2018 |
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 |
Lay User/Patient
|
Device Expiration Date | 11/28/2004 |
Device Model Number | KDR901 |
Device Catalogue Number | KDR901 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/19/2017
|
Initial Date FDA Received | 02/08/2018 |
Date Device Manufactured | 06/03/2003 |
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 |
Patient Age | 60 YR |
|
|