Brand Name | QUADRA ASSURA ICD |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
645 almanor avenue |
sunnyvale CA 94085 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. |
645 almanor avenue |
|
sunnyvale CA 94085 |
|
Manufacturer Contact |
elizabeth
boltz
|
15900 valley view court |
sylmar, CA 91342
|
8184932577
|
|
MDR Report Key | 8204117 |
MDR Text Key | 131705112 |
Report Number | 2938836-2018-13388 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/01/2019 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2016 |
Device Model Number | CD3367-40QC |
Device Lot Number | 4786905 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/25/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/21/2018
|
Initial Date FDA Received | 12/28/2018 |
Supplement Dates Manufacturer Received | 12/31/2018 04/30/2019
|
Supplement Dates FDA Received | 01/03/2019 05/01/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/14/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-0117-2017 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|