FDA Adverse Event
Injury
Summary report: N
INGENIO
MDR report key: 3930007
·
Received July 11, 2014
Report
- Report Number
- 2124215-2014-13750
- Event Type
- Injury
- Date Received
- July 11, 2014
- Date of Event
- June 24, 2014
- Report Date
- June 3, 2015
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- 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. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407520 | INGENIO | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | K063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| L| R | K063| 4469| 4136 |