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) |
MPRI |
road 149 km 56.3 |
|
villalba PR 00766 |
|
Manufacturer Contact |
lisa
robertson
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635262723
|
|
MDR Report Key | 8131738 |
MDR Text Key | 129293552 |
Report Number | 2649622-2018-19894 |
Device Sequence Number | 1 |
Product Code |
OJX
|
UDI-Device Identifier | 00643169601871 |
UDI-Public | 00643169601871 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
03/25/2019 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 08/01/2020 |
Device Model Number | 459888 |
Device Catalogue Number | 459888 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/02/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/09/2018 |
Initial Date FDA Received | 12/04/2018 |
Supplement Dates Manufacturer Received | 01/02/2019 01/02/2019 02/25/2019
|
Supplement Dates FDA Received | 01/23/2019 01/23/2019 03/25/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/21/2018 |
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 | 6949-65 LEAD, 5076-52 LEAD |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 85 YR |