Brand Name | ATTAIN PERFORMA |
Type of Device | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE |
Manufacturer (Section D) |
MPRI |
road 149 km 56.3 |
villalba PR 00766 |
|
Manufacturer (Section G) |
MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
8200 coral sea st ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 4831083 |
MDR Text Key | 15384264 |
Report Number | 2649622-2015-05722 |
Device Sequence Number | 1 |
Product Code |
OJX
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P080006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/19/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/19/2015 |
Device Model Number | 459888 |
Device Catalogue Number | 459888 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/19/2015
|
Initial Date FDA Received | 06/10/2015 |
Date Device Manufactured | 01/13/2014 |
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 Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 68 YR |
Patient Weight | 90 |