FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 2161551
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07405
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 15, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 DURING THE PATIENTS ABLATION PROCEDURE, THIS DEVICE DISPLAYED UNDERSENSING, NOISE AND OVERSENSING RESULTING IN PACING INHIBITION GREATER THAN TWO SECONDS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PHYSICIAN WAS UPSET WHEN THE DEVICE PACED DURING THE PROCEDURE. A TECHNICAL SERVICE CONSULTANT AND PRODUCT ENGINEER WAS CONSULTED AND RECOMMENDED VOO MODE DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | NVZ | GUIDANT CRM CLONMEL IRELAND | S606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | MISMATCH| S606| (B)(4) |