FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 4200348
·
Received October 24, 2014
Report
- Report Number
- 2017865-2014-17643
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 3, 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 Location
- WV, US
- 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 AN ASYMPTOMATIC PATIENT WAS PRESENTED TO THE EMERGENCY ROOM FOR A LEAD REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PULSE GENERATOR WENT INTO BACKUP MODE AFTER EXPOSURE TO ELECTROCAUTERY. A DEVICE DOWNLOAD RESTORED NORMAL DEVICE FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680159 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | (B)(4), (B)(4) |