Brand Name | AMPLIA MRI QUAD CRT-D SURESCAN |
Type of Device | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 9640447 |
MDR Text Key | 176755946 |
Report Number | 3004209178-2020-02059 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00643169720671 |
UDI-Public | 00643169720671 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/28/2020 |
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 |
Lay User/Patient
|
Device Expiration Date | 05/14/2021 |
Device Model Number | DTMB1QQ |
Device Catalogue Number | DTMB1QQ |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/02/2020 |
Initial Date FDA Received | 01/29/2020 |
Date Device Manufactured | 11/15/2019 |
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 |
Treatment | 407652 LEAD, 6935M62 LEAD, 478978 LEAD |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 83 YR |
Patient Weight | 79 |