FDA Adverse Event
Malfunction
Summary report: N
ACCENT SR RF OUS
MDR report key: 1896249
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05364
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- January 18, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL.
Description of Event or Problem · 1
INTERROGATION ON (B)(6) 2010 REPORTED THAT THE PULSE GENERATOR REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2009. THIS WAS DUE TO CAUTERY BEING USED DURING CARDIAC SURGERY ON (B)(6) 2010. A SOFTWARE DOWNLOAD WAS UNSUCCESSFUL. BACKUP VVI WAS NOTED THOUGH A SURFACE ECG SHOWED CAPTURE AT 60 PPM AND ASYNCHRONOUS PACING AT 100 PPM WITH THE MAGNET APPLIED. ONE HOUR LATER, THE DEVICE INTERROGATED NORMALLY. THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
THE PULSE GENERATOR WAS UPGRADED TO A DUAL CHAMBER AND ELECTIVELY EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCENT SR RF OUS | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM1210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |