FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3052545
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-03770
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 26, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT WAS INDICATED THIS LEAD WOULD NOT BE RETURNED. 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 FOLLOWING THE IMPLANTED PROCEDURE, THIS LEFT VENTRICULAR (LV) LEAD DISLODGED. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155138 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |