FDA Adverse Event
Injury
Summary report: N
VERITY ADX XL
MDR report key: 1223900
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03404
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMAP880086
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THE REPORTED PREMATURE BATTERY DEPLETION WAS DUE TO A DEFECTIVE INTEGRATED CIRCUIT. AFTER THE INTEGRATED CIRCUIT WAS REPLACED, NORMAL DEVICE FUNCTION ENSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING DIZZINESS. THE PULSE GENERATOR WAS INTERROGATED AND A "DEVICE AT ERI" ALERT MESSAGE DISPLAYED. THE DEVICE WAS REPLACED, AND THE PATIENT'S SYMPTOMS WERE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERITY ADX XL | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5056 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |