FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 1223826
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03460
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 30, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- 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 IN AUGUST 2008, THE PULSE GENERATOR BATTERY DATA WAS 2.65 V, 13 UA, AND 13 K, WITH AN ESTIMATED REMAINING LONGEVITY OF SIX MONTHS. IN 2008, BATTERY DATA WAS 2.54 V, 16 UA, 18.7 K, AND THE DEVICE HAD TRIPPED ELECTIVE REPLACEMENT INDICATOR. AS THE PATIENT WAS PACEMAKER DEPENDENT, THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |