Brand Name | QUADRA ASSURA CRT-D QUAD RF HV |
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 | 6593921 |
MDR Text Key | 76051379 |
Report Number | 2938836-2017-24249 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970013 |
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 |
09/23/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/26/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2018 |
Device Model Number | CD3365-40Q |
Device Catalogue Number | CD3365-40Q |
Device Lot Number | A000023359 |
Other Device ID Number | 05414734508292 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/10/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/19/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/25/2016 |
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 | 1458Q/75 (B)(4); 1688TC/46 (B)(4); 7122Q/58 (B)(4); CD3365-40Q (B)(4) |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 67 YR |