FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 4231339
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18122
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 9, 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
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS FOUND NORMAL LEAD CHARACTERISTICS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CLINIC VISIT, THE LEFT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS AND LEAD DISLODGEMENT WAS SUSPECTED. ON (B)(6) 2014, THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714989 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC., CRMD | 1458Q/75 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | 7122,BNY033019,DS2G002,UNK090914, |