Brand Name | JOT DX¿ ICM |
Type of Device | IMPLANTABLE CARDIAC MONITOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
sonali
arangil
|
15900 valley view court |
sylmar, CA 91342
|
|
MDR Report Key | 13974365 |
MDR Text Key | 288350644 |
Report Number | 2017865-2022-06889 |
Device Sequence Number | 1 |
Product Code |
MXC
|
UDI-Device Identifier | 05415067040046 |
UDI-Public | 05415067040046 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K163407 |
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,Followup |
Report Date |
05/17/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/01/2023 |
Device Model Number | DM4500 |
Device Catalogue Number | DM4500 |
Device Lot Number | S000083965 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/29/2022 |
Initial Date FDA Received | 04/01/2022 |
Supplement Dates Manufacturer Received | 05/14/2022
|
Supplement Dates FDA Received | 05/17/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/15/2021 |
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 |
Patient Sex | Female |
Patient Weight | 57 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|