Brand Name | CONFIRM |
Type of Device | IMPLANTABLE CARDIAC MONITOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
sylmar CA 91342 |
|
MDR Report Key | 10221589 |
MDR Text Key | 197285219 |
Report Number | 2017865-2020-08618 |
Device Sequence Number | 1 |
Product Code |
MXC
|
UDI-Device Identifier | 05415067027320 |
UDI-Public | 05415067027320 |
Combination Product (y/n) | N |
PMA/PMN Number | K163407 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
10/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/01/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/14/2020 |
Device Model Number | DM3500 |
Device Catalogue Number | DM3500 |
Device Lot Number | S000064107 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/15/2020 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/23/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 79 YR |
Patient Weight | 49 |
|
|