FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2151717
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-07620
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RECORDS INDICATE THIS PRODUCT REMAINS IMPLANTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION FROM ANOTHER MANUFACTURER'S REPRESENTATIVE THAT THE PATIENT IMPLANTED THIS PRODUCT DEVELOPED AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Life Threatening | 1861| 0158| 4475| 4450| 1270| MISMATCH |