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 | 7615883 |
MDR Text Key | 111557899 |
Report Number | 2124215-2018-07280 |
Device Sequence Number | 1 |
Product Code |
LWP
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/13/2018 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/06/2019 |
Device Model Number | L331 |
Other Device ID Number | ACCOLADE MRI |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
04/13/2018 |
Initial Date FDA Received | 06/19/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/06/2017 |
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 | 7736; 7741; L331 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 81 YR |