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
|
6515826168
|
|
MDR Report Key | 6767811 |
MDR Text Key | 81839430 |
Report Number | 2124215-2017-13996 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00802526559402 |
UDI-Public | (01)00802526559402(17)20180421 |
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 |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
06/27/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/04/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/21/2018 |
Device Model Number | U128 |
Other Device ID Number | VALITUDE X4 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 06/27/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/21/2016 |
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 | 4076; 4677; 5076; P1501DR; U128 |
Patient Age | 82 YR |