FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 2014303
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01755
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 9, 2010
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THE PULSE GENERATOR TO EXHIBIT NO TELEMETRY DUE TO MULTIPLE BITS FLIPPED IN THE PRODUCT CODE. AFTER THE PRODUCT CODE WAS DOWNLOADED, NORMAL FUNCTION ENSUED. THE DEVICE EXHIBITED CHARACTERISTICS INDICATIVE OF ELECTIVE REPLACEMENT INDICATOR (ERI). THIS WAS DUE TO A NORMALLY DEPLETED BATTERY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DESPITE INTERROGATING THE PULSE GENERATOR SEVERAL TIMES, IMPEDANCE AND BATTERY MEASUREMENTS COULD NOT BE RETRIEVED, NEITHER COULD LONGEVITY DATA. WITH A MAG- NET APPLIED, THE MAGNETIC FREQUENCY ROSE TO 95 BPM. THE PATIENT WAS DEPENDENT. THE PULSE GENERATOR WAS REMOVED AND 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 | 77 YR | Required Intervention |