FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 1050459
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01440
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE PATIENT WAS VISITING FROM BANGLADESH AND PRESENTED IN THE CLINIC COMPLAINING OF FEELING STIMULATION. THE ATRIAL LEAD EXHIBITED LOSS OF CAPTURE IN THE BIPOLAR CONFIGURATION. SENSING THRESHOLDS WERE AT 0.4 MV TO 0.5 MV. THE DEVICE WAS PROGRAMMED TO VDD MODE AND THE PATIENT WAS NO LONGER SYMPTOMATIC. THE PATIENT WAS ADVISED TO HAVE THE LEAD ASSESSED AFTER RETURNING HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1642T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |