Brand Name | SYNCHROMED II |
Type of Device | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
Manufacturer (Section D) |
MDT PUERTO RICO OPERATIONS CO |
rd 31 km 24 hm 4 |
juncos PR 00777 |
|
Manufacturer (Section G) |
MDT PUERTO RICO OPERATIONS CO |
rd 31 km 24 hm 4 |
|
juncos PR 00777 |
|
Manufacturer Contact |
david
gustafson
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635149628
|
|
MDR Report Key | 10821714 |
MDR Text Key | 216686109 |
Report Number | 3004209178-2020-19722 |
Device Sequence Number | 1 |
Product Code |
LKK
|
UDI-Device Identifier | 00643169100824 |
UDI-Public | 00643169100824 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P860004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/11/2020 |
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 | 05/28/2015 |
Device Model Number | 8637-40 |
Device Catalogue Number | 8637-40 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/17/2020 |
Initial Date FDA Received | 11/11/2020 |
Date Device Manufactured | 12/12/2013 |
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) |
Hospitalization;
Life Threatening;
|
Patient Age | 57 YR |