FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 1944752
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-20160
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPLACED. THE LEAD IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD HAD REPORTED PHRENIC NERVE STIMULATION. THE PHYSICIAN SUSPECTED THE LEAD HAD DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE HF LEAD | OJX | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |