FDA Adverse Event
Injury
Summary report: N
INTEGRITY AFX DR
MDR report key: 1050442
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01423
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 24, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 UPON INTERROGATION, AN ELECTIVE RE- PLACEMENT INDICATOR (ERI) TRIP WAS NOTED. THE ERI TRIP WAS CLEARED AND THE BATTERY DATA WAS THEN 2.72 V, 10 UA, AND 2.5 K. ANALYSIS OF THE DEVICE IMAGE SHOWED THAT THERE WAS INTERMITTENT HIGH CELL IMPEDANCE, AND LOW CELL VOLTAGE READ- INGS. IT WAS DETERMINED THAT ERI TRIPS WOULD LIKELY OCCUR INTERMITTENTLY, AND IT WAS RECOMMENDED THAT THE DEVICE BE REPLACED. THE PATIENT WAS NOT PACEMAKER DEPENDENT. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY AFX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5342 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |