Brand Name | AMPLIA MRI QUAD CRT-D |
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 |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7970848 |
MDR Text Key | 124364538 |
Report Number | 3004209178-2018-23177 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 00643169929647 |
UDI-Public | 00643169929647 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
10/16/2018 |
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 | 01/14/2019 |
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 |
09/25/2018 |
Initial Date FDA Received | 10/16/2018 |
Date Device Manufactured | 07/19/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-0962-2017 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 63 YR |
|
|