FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3041295
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01904
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P050046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 EROSION. THE PATIENT HAD A HEMATOMA, AND WAS SEEN AT THE CLINIC WHERE THEY NOTED THAT THE DEVICE HAD ERODED. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE DEVICE AND LEADS WERE ALL EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143168 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | N140| 0292| 4470| 4555 |