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 |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7744299 |
MDR Text Key | 115849720 |
Report Number | 2649622-2018-12667 |
Device Sequence Number | 1 |
Product Code |
OJX
|
UDI-Device Identifier | 00643169002715 |
UDI-Public | 00643169002715 |
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 |
Report Date |
10/02/2018 |
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 | 09/15/2017 |
Device Model Number | 429888 |
Device Catalogue Number | 429888 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/11/2018 |
Initial Date FDA Received | 08/02/2018 |
Supplement Dates Manufacturer Received | 08/08/2018
|
Supplement Dates FDA Received | 10/02/2018
|
Date Device Manufactured | 10/13/2015 |
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 | 6947M62 LEAD, DTBA1QQ CRTD, 5076-52 LEAD |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 66 YR |