FDA Adverse Event
Injury
Summary report: N
ENERGEN
MDR report key: 3912593
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-13427
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- May 30, 2014
- Report Date
- July 31, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND
- 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
ADDITIONAL INFORMATION RECEIVED THAT THE CULTURE TAKEN WAS POSITIVE BUT NOT FOR STAPH INFECTION. THE INFECTION WAS ONLY AT THE SUPERFICIAL SKIN THAT DIDN¿T MAKE ITS WAY DOWN TO THE INSIDE OF THE POCKET. NO ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT REMAINS IN SERVICE.
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 REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390437 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| L| R | 0276| 4457| 1194| E140 |