FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 1073430
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02214
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 9, 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
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE PULSE GENERATOR TO EXHIBIT BACK-UP MODE. THE PRODUCT CODE COULD NOT BE DOWNLOADED, THE DEVICE LOST TELEMETRY AND OUTPUT DUE TO THE BATTERY BEING DEPLETED. AFTER REPLACING THE BATTERY THE DEVICE FUNCTIONED NORMALLY. THE DEVICE WAS IMPLANTED FOR 40.77 MONTHS. THE DEVICE WAS EXPOSED TO ELECTROCAUTERY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR WAS NOT PACING, AND COULDN'T BE INTERROGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5380 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |