FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3211601
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08627
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 15, 2013
- Report Date
- May 15, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P050046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD ENDOCARDITIS AND AN INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310330 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| L| R | 4555| 4538| 0185| 0158| 1861| N119| H170| 4136| 4137| 4087 |