FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 3922273
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14369
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- May 19, 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
- GA, 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 PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP, UPON INTERROGATION THE PULSE GENERATOR EXHIBITED DIAGNOSTICS ANOMALY. THE DIAGNOSTICS WAS CLEARED AND THE DEVICE WAS INTERROGATED WITHOUT ANY COMPLICATIONS. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399341 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5826 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR |