FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 2173235
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10367
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 16, 2010
- Report Date
- June 14, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 SHORTLY AFTER IMPLANT, THE PATIENT WITH THIS DEVICE DEVELOPED A FEVER AND ANTIBIOTICS WERE PRESCRIBED. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |