Brand Name | MERLIN@HOME, RF TELEMETRY BASIC |
Type of Device | PACEMAKER DATA TRANSMITTER |
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 |
jaime
chavez
|
15900 valley view court |
sylmar, CA 91342
|
8184934022
|
|
MDR Report Key | 5673929 |
MDR Text Key | 45766150 |
Report Number | 2017865-2016-03135 |
Device Sequence Number | 1 |
Product Code |
DRG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Patient
|
Type of Report
| Initial,Followup |
Report Date |
04/11/2016 |
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 Model Number | EX1150 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/26/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/11/2016 |
Initial Date FDA Received | 05/23/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/02/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/10/2015 |
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 Age | 68 YR |
|
|