FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 6139705
·
Received December 1, 2016
Report
- Report Number
- 2017865-2016-07480
- Event Type
- Injury
- Date Received
- December 1, 2016
- Date of Event
- October 15, 2016
- Report Date
- October 17, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR ROUTINE DEVICE CHECK. UPON INTERROGATION, THE LEFT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLD. CHEST X-RAY WAS PERFORMED AND REVEALED THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES ON (B)(6) 2016. THE PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 790290 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1458Q/86 | A000025796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |