Brand Name | ATTAIN ABILITY PLUS |
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) |
MPRI |
road 149 km 56.3 |
|
villalba PR 00766 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7093846 |
MDR Text Key | 94079580 |
Report Number | 2649622-2017-15059 |
Device Sequence Number | 1 |
Product Code |
OJX
|
UDI-Device Identifier | 00613994719133 |
UDI-Public | 00613994719133 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P080006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/07/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 09/09/2015 |
Device Model Number | 429688 |
Device Catalogue Number | 429688 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/16/2017 |
Date Device Manufactured | 11/18/2013 |
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 | DTBA1D4 CRT-D, 6935M LEAD, 6725 ADAPTOR |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 75 YR |