FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3910492
·
Received July 2, 2014
Report
- Report Number
- 2124215-2014-09871
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 14, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 WAS FOUND TO HAVE DISLODGED. THIS LV LEAD WAS SURGICALLY ABANDONED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388044 | ACUITY | IMPLANTABLE HF LEADS | LWP | CPI - DEL CARIBE | 4593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| L| R | 4591| 4593| 4135| N140| 4554| 0295 |