FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 4231358
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18138
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 3, 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
- CA
- Reporter Occupation
- NURSE
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 DURING ROUTINE FOLLOW-UP, THE LEFT VENTRICULAR LEAD WAS FOUND TO BE PACING IN THE ATRIUM. X-RAY IMAGING CONFIRMED THAT THE LEAD HAD DISLODGED. A REPLACEMENT PROCEDURE WAS RECOMMENDED BUT NOT SCHEDULED.
Description of Event or Problem · 1
NEW INFORMATION REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715620 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |