FDA Adverse Event
Injury
Summary report: N
INTEGRITY MICRO
MDR report key: 1050363
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01264
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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 IN BACK-UP MODE. TWO ATTEMPTS TO PERFORM A DOWNLOAD FAILED. THE ERI BYTE WAS CHECKED INDICATING THE DEVICE WAS NOT AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE MEASURED BATTERY DATA IN 2007 WAS 2.56 V, 14 UA, 8.7 KOHMS WITH AN ESTIMATED LONGEVITY OF ABOUT 2 MONTHS UNTIL ERI. THE DEVICE WAS SUBSEQUENTLY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY MICRO | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5336 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |