Brand Name | QUADRA ASSURA MP ICD |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
645 almanor avenue |
sunnyvale CA 94085 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
645 almanor avenue |
|
sunnyvale CA 94085 |
|
Manufacturer Contact |
denise
johnson
|
5050 nathan lane north |
plymouth, MN 55442
|
6517564470
|
|
MDR Report Key | 6404668 |
MDR Text Key | 69946133 |
Report Number | 2938836-2017-18375 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
Report Date |
02/15/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/14/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2018 |
Device Model Number | CD3369-40Q |
Device Lot Number | A000033272 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/15/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/17/2016 |
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 | 1457Q/75 DBE010195; 2088TC/46 CAT115640; 7122Q/58 BKB027806 |
Patient Age | 56 YR |