FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3223498
·
Received July 12, 2013
Report
- Report Number
- 2124215-2013-10463
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 11, 2013
- 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
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 (LV) LEAD EXHIBITED DIAPHRAGMATIC STIMULATION AND INCREASED PACING THRESHOLD MEASUREMENTS. A CHEST X-RAY CONFIRMED A LEAD DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321727 | ACUITY | IMPLANTABLE HF LEAD | OJX | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |