FDA Adverse Event
Injury
Summary report: N
INGENIO
MDR report key: 3913510
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-13393
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- June 6, 2014
- Report Date
- September 26, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM FIELD REPRESENTATIVE STATING THAT THE POCKET SITE WAS OPENED AND HEMATOMA WAS SUSPECTED. THERE WAS NO INFORMATION OBTAINED TO CONFIRM THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391410 | INGENIO | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | J176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R | 4470| J176| 4471 |