FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 3213251
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09193
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- April 10, 2013
- Report Date
- May 24, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE THE PATIENT IMPLANTED WITH THIS PACEMAKER WAS IN THE INTENSIVE CARE UNIT FOR AN UNRELATED REASON, AP-VP WAS OBSERVED AT THE MAX SENSOR RATE OF 130 BEATS PER MINUTE (BPM). THE PACING RESOLVED WHEN THE MINUTE VENTILLATION (MV) FEATURE WAS PROGRAMMED OFF. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED MV INTERACTION WITH HOSPITAL EQUIPMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313013 | ALTRUA | NVZ | GUIDANT CRM CLONMEL IRELAND | S606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | S606| MISMATCH| 1488TC |