FDA Adverse Event
Malfunction
Summary report: N
ENTITY DR
MDR report key: 1073245
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01959
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 2, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE CHANGEOUT, THE PACEMAKER WAS PROGRAMMER BIPOLAR, DDD AT 70 PACES PER MINUTE (PPM). WHEN THE DEVICE WAS REMOVED FROM THE POCKET, IT PACED AT 30 PPM. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5326 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |