FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3953818
·
Received July 23, 2014
Report
- Report Number
- 2124215-2014-14071
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- June 12, 2014
- Report Date
- June 16, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWP
- PMA / PMN Number
- G050163
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION OF THE LEADS THROUGH THE SKIN. THE PATIENT HAD A HEMATOMA FORM IN STOMACH, PERIODS WHERE BLOOD PRESSURE DROPPED AND BRUISING FROM HEPARIN SHOTS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431961 | ACUITY | IMPLANTABLE HF LEAD | LWP | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | 5076| 4592| 6947| 1853| H217| 4543| 4469| N119 |