FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL SR
MDR report key: 4143193
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05678
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- July 31, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR ROUTINE FOLLOW UP. PULSE GENERATOR EXHIBITED INTERMITTENT VENTRICULAR UNDERSENSING. DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31916 | ZEPHYR XL SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC. CRMD | 5626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |