FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX XL DR
MDR report key: 1955896
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-01138
- Event Type
- Injury
- Date Received
- January 10, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- 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 THAT THE PULSE GENERATOR HAD A DEFECTIVE CAPACITOR. THIS CAUSED THE DEVICE TO EXHIBIT HIGH CURRENT DRAIN, RESULTING IN PREMATURE BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UPON INTERROGATION THE PACEMAKER DISPLAYED LESS THAN ONE YEAR REMAINING LONGEVITY; LOWER THAN EXPECTED WITH AN IMPLANT DATE OF (B)(6) 2009. HIGH CURRENT DRAIN OF 69 UA AGAINST LOW BATTERY IMPEDANCE OF 1.4 KOHMS WAS NOTED. THE PULSE GENERATOR WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5386 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |