FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 3333627
·
Received September 9, 2013
Report
- Report Number
- 2017865-2013-06384
- Event Type
- Malfunction
- Date Received
- September 9, 2013
- Date of Event
- July 2, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- 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 PULSE GENERATOR DISPLAYED - DIAGNOSTIC DATA IS INVALID - MESSAGE UPON INTERROGATION. THE DIAGNOSITCS DATA WAS CLEARED FROM THE DEVICE AND IT COULD BE INTERROGATED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449990 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |