FDA Adverse Event
Malfunction
Summary report: N
ZEPHYR XL SR
MDR report key: 2983742
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01610
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 12, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 PATIENT HAD PRESENTED FOR AN ANGIOPLASTY PROCEDURE AND THE DEVICE WAS PROGRAMMED TO A BASE RATE OF 75. DURING THE FLUOROSCOPY PROCEDURE THE DEVICE MSR RATE INCREASED TO 140 PPM AND THE PT'S BLOOD PRESSURE DROPPED. THE CT SCANNING WAS BELIEVED TO HAVE CAUSED THE INCREASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87868 | ZEPHYR XL SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5626 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |