FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 2014034
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01782
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- December 6, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE PREPARING FOR IMPLANT, INTERROGATION OF THE PULSE GENERATOR TOOK A LONG TIME AND WHEN COMPLETE, AN ERROR MESSAGE APPEARED PROMPTING TO REBOOT THE PROGRAMMER AND REINTERROGATE THE DEVICE . INTERROGATION OF THE DEVICE A SECOND TIME WAS AGAIN SLOW. THE DEVICE WAS NOT IMPLANTED.
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 | 5820 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |