FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 4073676
·
Received September 9, 2014
Report
- Report Number
- 2017865-2014-16688
- Event Type
- Malfunction
- Date Received
- September 9, 2014
- Date of Event
- July 10, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 PATIENT PRESENTED IN CLINIC AND UPON INTERROGATION OF THE PULSE GENERATOR, A DEVICE PARAMETER ERROR MESSAGE WAS DISPLAYED. THE DEVICE WAS REPROGRAMMED TO THE ORIGINAL SETTINGS. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554263 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |