FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL DR
MDR report key: 4121590
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-07692
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- October 20, 2011
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
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 THERE WAS LOW HEART RATE BINNING ON THE HEART RATE HISTOGRAM WHILE INTERROGATING THE DEVICE WITH THE MERLIN PROGRAMMER. THE PATIENT WILL BE SENT HOME AND WILL BE MONITORED FOR FURTHER OCCURENCES. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32613 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC. CRMD | 5826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |