FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX XL DR
MDR report key: 1222925
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03264
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 13, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT ARRIVED IN CLINIC WITH A HIGH VENTRICULAR RATE ON THE STORED ELECTROGRAM. THE STRIPS WERE REVIEWED AND NOISE WAS SEEN ON BOTH CHANNELS ON THREE SEPARATE DAYS AT AROUND THE SAME TIME. THE PATIENT WAS TO BE MONITORED AND EVALUATED AGAIN IN A FEW WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5386 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |