Brand Name | ENDOTAK RELIANCE G |
Type of Device | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
4100 hamline avenue north |
saint paul MN 55112 |
|
Manufacturer (Section G) |
GUIDANT PUERTO RICO, B.V. |
no. 12, road 698 |
, |
dorado PR 00646 3311 |
|
Manufacturer Contact |
timothy degroot
|
4100 hamline avenue north |
, |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 8859833 |
MDR Text Key | 153236765 |
Report Number | 2124215-2019-16066 |
Device Sequence Number | 1 |
Product Code |
LWS
|
UDI-Device Identifier | 00802526531194 |
UDI-Public | 00802526531194 |
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 |
Other
|
Type of Report
| Initial |
Report Date |
08/05/2019 |
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 | 04/07/2010 |
Device Model Number | 0185 |
Device Catalogue Number | 0185 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/26/2019 |
Initial Date FDA Received | 08/05/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/07/2008 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Other;
|
Patient Age | 93 YR |