FDA Adverse Event
Injury
Summary report: N
ENERGEN
MDR report key: 3240030
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-09492
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 23, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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. PATIENT HAS FISTULA ON RIGHT AND HAD PRIOR STERNOTOMY BUT DOES NOT PRECLUDE SICD. SENSING ISSUES CREATED BY STAPLE WAS ALSO NOTED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE DEVICE WAS EXPLANTED AND OUT OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339445 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| R | 0293| E140 |