FDA Adverse Event
Malfunction
Summary report: N
QUARTET
MDR report key: 3923838
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14821
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- April 29, 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 Location
- NM, 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 THE LEFT VENTRICULAR LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS AND LOSS OF CAPTURE WAS NOTED. THE DEVICE OUTPUT SETTING WERE INCREASED AND THE LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 402004 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |