FDA Adverse Event
Malfunction
Summary report: N
SYMPHONY
MDR report key: 1162503
·
Received September 16, 2008
Report
- Report Number
- 9610579-2008-00031
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 7, 2008
- Report Date
- September 16, 2008
- Manufacturer
- ELA MEDICAL
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE ANALYSIS IS PENDING.
Description of Event or Problem · 1
DURING ROUTINE FOLLOW UP IN 2008, ABSENCE OF CAPTURE AND SENSING WAS OBSERVED; IN ADDITION, HIGH LEAD IMPEDANCES WERE OBTAINED DURING THAT FOLLOW UP. THEREFORE, THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMPHONY | DXY - IMPLANTABLE CARDIAC PACEMAKER | DXY | ELA MEDICAL | 2550 | S061005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |