FDA Adverse Event
Injury
Summary report: N
INGENIO
MDR report key: 2911242
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16587
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
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. THE LEADS WERE EXPLANTED SUCCESSFULLY, HOWEVER, THE DEVICE IS CURRENTLY BEING USED AS AN EXTERNAL PACEMAKER WHILE THE INFECTION CLEARS. A NEW RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED THROUGH THE JUGULAR VEIN TO USE TEMPORARILY WITH THE PACEMAKER. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18909 | INGENIO | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | K173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | 1232| 4285| 4271| K173| 1298 |