FDA Adverse Event
Injury
Summary report: N
ZEPHYR DR
MDR report key: 3920473
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14073
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- April 3, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 IN CLINIC FOR FOLLOW-UP AND THE PULSE GENERATOR WAS FOUND IN BACKUP MODE. FOLLOWING A DOWNLOAD, NORMAL DEVICE FUNCTION RESUMED. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396055 | ZEPHYR DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5820 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Required Intervention |