Brand Name | INGEVITY |
Type of Device | IMPLANTABLE LEAD |
Manufacturer (Section D) |
CPI - DEL CARIBE |
guidant puerto rico b. v. |
dorado PR |
|
Manufacturer (Section G) |
CPI - DEL CARIBE |
guidant puerto rico b. v. |
|
dorado PR |
|
Manufacturer Contact |
sonali
vasekar
|
4100 hamline ave. n |
st. paul, MN
|
6515824786
|
|
MDR Report Key | 6242122 |
MDR Text Key | 64506586 |
Report Number | 2124215-2016-19940 |
Device Sequence Number | 1 |
Product Code |
NVN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150012/S000 |
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 |
11/18/2016 |
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 | 10/12/2018 |
Device Model Number | 7740 |
Other Device ID Number | INGEVITY MRI |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
11/18/2016
|
Initial Date FDA Received | 01/11/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/12/2016 |
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 | 4092; 4469; 7740; 7741; L311; L321 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 88 YR |