FDA Adverse Event
Malfunction
Summary report: N
ACUITY
MDR report key: 4144350
·
Received October 6, 2014
Report
- Report Number
- 2124215-2014-17720
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 24, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS HOSPITALIZED DUE TO HEART FAILURE. AN X-RAY REVEALED THAT THIS LEFT VENTRICULAR LEAD HAD DISLODGED AND RESULTED IN PACING FAILURE. THE LEAD WILL BE REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623730 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | 4470| 0695| 4554| P162 |