FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 2014165
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01761
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 2, 2010
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING LEAD REPLACEMENT, R-WAVES VIA AN ANALYZER MEASURED GREATER THAN 20.0 MV. AT A PRIOR FOLLOW- UP, VENTRICULAR UNDERSENSING WAS OBSERVED IN BOTH CONFIGURATIONS EVEN WHEN SENSITIVITY WAS PROGRAMMED TO THE HIGHEST SETTING. THEREFORE THE PULSE GENERATOR WAS REMOVED AND REPLACED.
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 | Required Intervention |