FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 2173130
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10396
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 15, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECIEVED INFORMATON THAT SHORTLY AFTER THE IMPLANT PROCEDURE THIS LEFT VENTRICULAR LEAD DISLODGED. ANOTEHR PROCEDURE WAS PERFORMED TO REPLACE THIS LEAD. IT IS UNKNOWN WEATHER THIS LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |