Brand Name | ATTAIN STABILITY |
Type of Device | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE |
Manufacturer (Section D) |
MEDTRONIC B.V. |
earl bakkenstraat 10 |
heerlen 6422 PJ |
NL 6422 PJ |
|
Manufacturer (Section G) |
MEDTRONIC B.V. |
earl bakkenstraat 10 |
|
heerlen 6422 PJ |
NL
6422 PJ
|
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 8140808 |
MDR Text Key | 129575725 |
Report Number | 3002807561-2018-00041 |
Device Sequence Number | 1 |
Product Code |
OJX
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | P080006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/07/2018 |
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 | 09/08/2016 |
Device Model Number | 20066 |
Device Catalogue Number | 20066 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/16/2018
|
Initial Date FDA Received | 12/07/2018 |
Date Device Manufactured | 09/22/2014 |
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 |
Treatment | DTBA2D1 ICD, 6947 LEAD, 20066 LEAD |
Patient Age | 66 YR |