FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 6171929
·
Received December 13, 2016
Report
- Report Number
- 2017865-2016-07794
- Event Type
- Injury
- Date Received
- December 13, 2016
- Date of Event
- November 2, 2016
- Report Date
- November 2, 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING DIAPHRAGMATIC STIMULATION. UPON INTERROGATION THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE DUE TO DISLODGEMENT. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821275 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1458Q/86 | A000000893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |