Brand Name | CONFIRM |
Type of Device | IMPLANTABLE CARDIAC MONITOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
robert
greenleaf
|
15900 valley view court |
sylmar, CA 91342
|
8184932577
|
|
MDR Report Key | 7898961 |
MDR Text Key | 121443072 |
Report Number | 2017865-2018-14146 |
Device Sequence Number | 1 |
Product Code |
MXC
|
UDI-Device Identifier | 05415067027320 |
UDI-Public | 05415067027320 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K163407 |
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,Followup |
Report Date |
11/06/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/29/2019 |
Device Model Number | DM3500 |
Device Catalogue Number | DM3500 |
Device Lot Number | S000056926 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/26/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/12/2018 |
Initial Date FDA Received | 09/21/2018 |
Supplement Dates Manufacturer Received | 11/21/2018 09/12/2018 10/11/2019
|
Supplement Dates FDA Received | 12/04/2018 08/12/2019 11/06/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/15/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 2017865-10/11/19-001-C |
Patient Sequence Number | 1 |