FDA Adverse Event
Injury
Summary report: N
AFFIRMITY
MDR report key: 1896665
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05272
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 8, 2010
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS FOUND THAT THE PULSE GENERATOR WAS PROGRAMMED TO VVI MODE AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS ACTIVATED, AS RECEIVED. AFTER PROGRAMMING TO DDD MODE AT 60 PPM AND CLEARING THE ERI INDICATOR, MEASURED DATA INDICATED NORMAL PRE-ERI CHARACTERISTICS. THE PACING PERFORMANCE OF THE DEVICE WAS MONITORED DURING MECHANICAL STRESS TESTING FOR OVER 24 HOURS AND MEASUREMENTS INDICATED NO DISCREPANCIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE AWAITING PULSE GENERATOR CHANGE OUT DUE TO LOW BATTERY VOLTAGE, THE SET RATE OF 30 BPM SUDDENLY INCREASED TO 92 BPM. THERE WAS NO IMPAIRMENT TO THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFIRMITY | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5338 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |