FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX DR
MDR report key: 1073286
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02085
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED. ATTEMPTS WERE MADE WITH TWO DIFFERENT PROGRAMMERS. THE DEVICE APPEARED TO BE WORKING NORMALLY IN VDD MODE WITH A MAGNET RATE OF 97.3 BPM. BASED ON THE MEASURED BATTERY DATA, THE DEVICE HAD ELEVEN MONTHS REMAINING LONGEVITY.
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 |