FDA Adverse Event
Malfunction
Summary report: N
INTEGRITY AFX
MDR report key: 2014041
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01730
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- December 29, 2010
- 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
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS PROGRAMMED TO DOO MODE AT A RATE OF 70 PPM BUT THE PACED RATE DECREASED TO APPROXIMATELY 30 PPM FOR LESS THAN A MINUTE AND LOSS OF OUTPUT OCCURRED. THE BATTERY VOLTAGE WAS 2.59 V. THE DEVICE WAS EXPOSED TO ELECTROCAUTERY. THE DEVICE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY AFX | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5346 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |