Brand Name | ZIO XT PATCH |
Type of Device | RECORDER, MAGNETIC TAPE, MEDICAL |
Manufacturer (Section D) |
IRHYTHM TECHNOLOGIES, INC |
699 8th st suite 600 |
san francisco CA 94103 |
|
Manufacturer (Section G) |
IRHYTHM TECHNOLOGIES, INC |
6550 katella avenue, suite 200 |
|
cypress CA 90630 |
|
Manufacturer Contact |
mazi
kiani
|
699 8th st suite 600 |
san francisco, CA
|
9494132147
|
|
MDR Report Key | 15353156 |
MDR Text Key | 299262021 |
Report Number | 3007208829-2022-00040 |
Device Sequence Number | 1 |
Product Code |
DSH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121319 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/12/2022 |
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
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/16/2022 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/16/2022 |
Initial Date FDA Received | 09/02/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/20/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 19 YR |
Patient Sex | Female |
|
|