FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 1962243
·
Received January 18, 2011
Report
- Report Number
- 2124215-2011-00900
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- November 28, 2010
- Report Date
- November 28, 2010
- 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
TECHNICAL SERVICES DISCUSSED PROGRAMMING AUTOMATIC CAPTURE TO OFF AND INCREASING PACING OUTPUTS. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED LOSS OF CAPTURE. VENTRICULAR TACHYCARDIA EPISODES WERE STORED DUE TO THE OBSERVED LOSS OF CAPTURE. A FEW DAYS AFTER THE EPISODES OCCURRED, THE PATIENT EXPERIENCED A SYNCOPE EPISODE. THERE WERE NO STORED EPISODES RECORDED ON THE DAY THE PATIENT WAS SYNCOPAL.
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 | 75 YR | 4088| 4470| S606 |