FDA Adverse Event
Injury
Summary report: N
VERITY ADX SR
MDR report key: 1073307
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02101
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 22, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL FINAL ANALYSIS FOUND A FALSE ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO ERRONEOUS MEASURED DATA. THE ERI INDICATOR WAS CLEARED AND THE DEVICE EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS THROUGHOUT ALL TESTS.
Description of Event or Problem · 1
HIGH LEAD IMPEDANCE WAS REPORTED. WHEN THE LEAD WAS EXPLANTED BLOOD WAS NOTED INSIDE THE HEADER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERITY ADX SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5156 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |