Brand Name | UNIFY 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 |
robert
greenleaf
|
15900 valley view court |
sylmar, CA 91342
|
8184932577
|
|
MDR Report Key | 7145270 |
MDR Text Key | 95719685 |
Report Number | 2938836-2017-35413 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup,Followup |
Report Date |
06/10/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2016 |
Device Model Number | CD3361-40QC |
Device Lot Number | 4877893 |
Other Device ID Number | 05414734508247 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/02/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/13/2017
|
Initial Date FDA Received | 12/24/2017 |
Supplement Dates Manufacturer Received | 12/24/2017 05/30/2018
|
Supplement Dates FDA Received | 12/27/2017 06/10/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/12/2014 |
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-0116-2017 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 76 YR |