FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 2173258
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10503
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 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
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 FOLLOWING A CARDIOVERSION FOR AN ATRIAL FIBRILLATION ARRHYTHMIA, PACING INHIBITION WITH APPROXIMATELY SEVEN TO EIGHT SECONDS OF ASYSTOLE ENSUED. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE NOTED THAT THE PACEMAKER RECOVERED AND WAS CURRENTLY WORKING APPROPRIATELY. THE PATIENT REPORTED FEELING BETTER POST CARDIOVERSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | 4457| 4469| S603 |