FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 1223884
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03418
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 24, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI), WITH A BATTERY VOLTAGE OF 2.53 V. MEASURED DATA FROM 2008 WAS 2.69 V, 10 UA, AND 7.1 KOHMS, WITH AN ESTIMATED REMAINING LONGEVITY OF 1.25 TO 1.5 YEARS. NO CHANGES HAD BEEN MADE TO THE PROGRAMMED PARAMETERS SINCE THAT TIME THAT WOULD SPEED UP THE BATTERY RUNDOWN. THE DEVICE WAS REREPLACED.
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 | 78 YR | Required Intervention |