FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 3925792
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15260
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- April 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- OJX
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR 6 MONTH FOLLOW-UP. THE LEFT VENTRICLE LEAD EXHIBITED LOSS OF CAPTURE. CHEST X-RAY CONFIRMED THE LEAD HAD DISLODGED INTO THE RIGHT ATRIUM. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404932 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |