FDA Adverse Event
Malfunction
Summary report: N
INGENIO
MDR report key: 3904491
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-08746
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- March 12, 2014
- Report Date
- April 16, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CONFIRMED WITH THE CALLER THAT CONNECTIONS WERE SECURE. IMPEDANCE, THRESHOLDS AND SENSING MEASUREMENTS WERE ALL GOOD. THE NOISE WAS RESOLVED BY THE END OF THE IMPLANT PROCEDURE. 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 DURING IMPLANT OF THIS SYSTEM, INTERMITTENT NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384911 | INGENIO | IMPLANTABLE CHF GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | V173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | 4469| V173| 4549| 4087 |