FDA Adverse Event
Injury
Summary report: N
ZEPHYR XL DR
MDR report key: 1073228
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02042
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- 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 THE ATRIAL LEAD EXHIBITED GREATER THAN 2000 OHMS IMPEDANCE IN BOTH CONFIGURATIONS. WHEN THE LEAD WAS CONNECTED TO THE ANALYZER CAPTURE THRESHOLDS WERE 0.75 V, P-WAVES WERE 3.5 MV AND LEAD IMPEDANCE WAS 400 OHMS. WHEN THE LEAD WAS RECONNECTED TO THE PULSE GENERATOR THERE WAS NO CAPTURE AND LEAD IMPEDANCE WAS GREATER THAN 2000 OHMS. WITH A NEW PULSE GENERATOR ATRIAL LEAD NUMBERS WERE NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |