FDA Adverse Event
Injury
Summary report: N
INCEPTA
MDR report key: 4150875
·
Received October 8, 2014
Report
- Report Number
- 2124215-2014-17942
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 22, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
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 DEVICE WAS EXPLANTED AND NO LONGER IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633219 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| L| R | 4469| E102| 0180| MISMATCH| 4542| N161| 4968 |