FDA Adverse Event
Malfunction
Summary report: N
ANTHEM RF
MDR report key: 1896707
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05401
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 17, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PULSE GENERATOR OUTPUT WAS PROGRAMMED LESS THAN 2.0 V, 0.5 BIPOLAR, INTERMITTENT LOSS OF CAPTURE OCCURRED, BUT AT 2.0 V, 0.5 MS BIPOLAR, PHRENIC NERVE STIMULATION BEGAN WHEN THE PATIENT LAY ON HIS SIDE. PHRENIC NERVE STIMULATION WORSENED IN THE UNIPOLAR CONFIGURATION. THE DEVICE WAS PROGRAMMED TO BIPOLAR AND AT 0.3 MS AND 1.0 MS PULSE WIDTH, THERE WAS STILL NO CAPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANTHEM RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM3210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |