FDA Adverse Event
Injury
Summary report: N
VERITY DR
MDR report key: 1050380
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01366
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 1, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT, ATRIAL THRESHOLDS WERE HIGHER THAN AT IMPLANT. THE NEXT DAY, THE PATIENT PRESENTED TO THE OPERATING ROOM WHERE ALLIGATOR CLIPS WERE CONNECTED TO THE LEAD AND ATRIAL THRESHOLDS WERE GOOD. THEREFORE THE PULSE GENERATOR WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5356 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |