Brand Name | PROMOTE PLUS CRT-D, DF-4 CONNECTOR |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC., CRMD |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC., CRMD |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
cary
lawler
|
645 almanor avenue |
sunnyvale, CA 94085
|
8184932621
|
|
MDR Report Key | 3669305 |
MDR Text Key | 22263012 |
Report Number | 2938836-2014-08369 |
Device Sequence Number | 1 |
Product Code |
NIK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/09/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2011 |
Device Model Number | CD3211-36Q |
Device Catalogue Number | SMTFY999 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 12/20/2013 |
Device Age | 46 MO |
Event Location |
Hospital
|
Date Manufacturer Received | 12/20/2013 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/25/2010 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 72 YR |
|
|