FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 2172957
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10773
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 10, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCT REMAINS 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 THIS LEFT VENTRICULAR WAS SUCCESSFULLY REPOSITIONED TEN MONTHS POST IMPLANT DUE TO LEAD DISLODGEMENT. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | T135| 4555| 4470| N119| 0158| A155| 4087 |