Brand Name | IDENTITY XL DR |
Type of Device | IMPLANTABLE PACEMAKER PULSE GENERATOR |
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
|
15900 valley view court |
sylmar, CA 91342
|
8184932621
|
|
MDR Report Key | 3923132 |
MDR Text Key | 12699787 |
Report Number | 2017865-2014-14461 |
Device Sequence Number | 1 |
Product Code |
LWP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Remedial Action |
Notification |
Type of Report
| Initial,Followup,Followup |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/09/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2004 |
Device Model Number | 5376 |
Device Catalogue Number | SMTFY999 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/12/2014 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/08/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/02/2003 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z0298 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 65 YR |
|
|