FDA Adverse Event
Injury
Summary report: N
META DDDR
MDR report key: 1223728
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03212
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- October 10, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE PACEMAKER WAS PROGRAMMED TO VVIR DUE TO CHRONIC ATRIAL FIBRILLATION AND WAS PACING AT 120 PULSES PER MINUTE (PPM). A MAGNET WAS PLACED OVER THE DEVICE AND IT PACED AT 90 PPM. UPON REMOVAL OF THE MAGNET, THE DEVICE WENT BACK TO 120 PPM. RATE RESPONSE WAS PROGRAMMED TO 12 IN 2003. IT WAS REPRO- GRAMMED TO 1, AND THE RATE WENT DOWN TO 88 PPM. THERE WAS CONCERN ABOUT THE SENSOR, SO THE DEVICE WAS TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | META DDDR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1256 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |