FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 2040776
·
Received April 6, 2011
Report
- Report Number
- 2124215-2011-03231
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 11, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER APPROXIMATELY 4.8 MONTHS, THE LEFT VENTRICULAR (LV; 4555) LEAD HAD DISLODGED. DURING A REVISION PROCEDURE, A NEW LV LEAD (4543) WAS ATTEMPTED, BUT UNABLE TO STABILIZE IN POSITION AND WAS NOT IMPLANTED. THE ORIGINAL LV LEAD WAS EXPLANTED. ANOTHER LV (4555) LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Life Threatening| R | 0181| 4543| N119| 4555| 4473 |