Brand Name | ACCOLADE |
Type of Device | IMPLANTABLE PULSE GENERATOR |
Manufacturer (Section D) |
GUIDANT CRM CLONMEL IRELAND |
guidant ireland |
clonmel, tipperary ireland |
|
Manufacturer (Section G) |
GUIDANT CRM CLONMEL IRELAND |
guidant ireland |
|
clonmel, tipperary ireland |
|
Manufacturer Contact |
tim
degroot
|
4100 hamline ave. n |
st. paul, MN
|
6515824786
|
|
MDR Report Key | 6486483 |
MDR Text Key | 72584557 |
Report Number | 2124215-2017-05843 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00802526559402 |
UDI-Public | (01)00802526559402(17)20181018 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/21/2017 |
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 | 10/18/2018 |
Device Model Number | U128 |
Other Device ID Number | VALITUDE X4 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
02/27/2017 |
Initial Date FDA Received | 04/12/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/02/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/18/2016 |
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 | 4137; 4677; MISMATCH; U128 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 87 YR |