FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 1952260
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23613
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- G050163
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE SYSTEM AND LEADS WERE EXPLANTED DUE TO A PATIENT INFECTION. DURING THE PROCEDURE, A NEW RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED IN THE PACER DEPENDENT PATIENT AND CONNECTED TO THE CHRONIC DEVICE OUTSIDE THE PATIENT'S BODY UNTIL A NEW SYSTEM WOULD BE IMPLANTED THE FOLLOWING WEEK. NO FURTHER COMPLICATIONS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE HF LEAD | OJX | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R | 4135| 4137| 4592| 1291| N119| 4136| 7122 |