FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX VDR
MDR report key: 2240057
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05905
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- May 30, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- NA
- 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
FINAL ANALYSIS FOUND THE PULSE GENERATOR IN BACKUP MODE. THE DEVICE WAS AT END OF LIFE (EOL). NO INFORMATION WAS RECEIVED FROM THE FIELD REGARDING THE DEVICE SETTINGS. AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE, NORMAL FUNCTION ENSUED.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE END OF LIFE. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX VDR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5480 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |