FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 1223885
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03419
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- September 15, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 ONE WEEK POST IMPLANT THE PULSE GENERATOR COULD NOT BE INTERROGATED. THE HARDWARE ELECTIVE REPLACEMENT INDICATOR (ERI) BYTE WAS CHECKED AND INDICATED THAT THE DEVICE HAD NOT REACHED HARDWARE ERI. A SOFTWARE DOWNLOAD WAS ATTEMPTED WITHOUT SUCCESS, LEAVING THE PACEMAKER IN BVVI OPERATION. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IN BVVI MODE AS THE PATIENT WAS ELDERLY WITH MULTIPLE COMORBIDITIES.
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 |