FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3240200
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-09556
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 INVOLVED IN AN INFECTION. ALTHOUGH AN INFECTION WAS CONFIRMED, THE PHYSICIAN DECIDED NOT TO EXTRACT THE SYSTEM BECAUSE THE ANTIBIOTIC THERAPY WORKED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339378 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| L| R | E162| 0293| 4136 |