FDA Adverse Event
Malfunction
Summary report: N
QUARTET
MDR report key: 3923917
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14858
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- May 16, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 THERE WAS DIFFICULTY POSITIONING THE LEFT VENTRICULAR LEAD DURING IMPLANT. AN ACCEPTABLE PACING THRESHOLD COULD NOT BE OBTAINED AND SOME POSITIONS CAUSED PHRENIC NERVE STIMULATION. THE LEAD WAS REMOVED AND A REPLACEMENT COULD NOT BE IMPLANTED AS WELL. PLANS WERE MADE TO IMPLANT AN EPICARDIAL LEFT VENTRICULAR LEAD AT A FUTURE DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402123 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1458Q/86, (B)(4) |