FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX XL DR
MDR report key: 1073101
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01989
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- February 21, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THE DEVICE IN BACK UP OPERATION AND THE PRODUCT CODE INTACT. THE BATTERY WAS FOUND AT EOL VOLTAGE DUE TO NORMAL BATTERY DEPLETION, BUT THE DEVICE DID NOT MEET 75 % OF NOMINAL LONGEVITY AND NO REPRESENTATIVE FIELD SETTINGS WERE RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5386 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |