FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 3926545
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15714
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- April 22, 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
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE OPERATING ROOM FOR A SCHEDULED ROUTINE PULSE GENERATOR CHANGEOUT PROCEDURE. DURING THE PROCEDURE, THE PULSE GENERATOR COULD NOT BE INTERROGATED AND EXHIBITED NO OUTPUT. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403259 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |