FDA Adverse Event
Injury
Summary report: N
SYMMETRY DR
MDR report key: 1223646
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03220
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- July 15, 2008
- Report Date
- August 18, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER AND MAUDE EVENT REPORT NUMBER.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN ICU AFTER A ROUTINE CAROTID ENDARTERECTOMY, THE PATIENT BECAME UNRESPONSIVE AND VENTRIC- ULAR FIBRILLATION (VF) WAS SEEN. REVIEW OF THE MONITORING STRIPS SHOWED A PACED BEAT ON THE T WAVE. CARDIOPULMONARY RESUSCITATION COMMENCED FOR ABOUT 90 SECONDS. THE VF CEASED SPONTANEOUSLY, DUAL CHAMBER PACING RESUMED AND THE PATIENT RECOVERED. INTERROGATION OF THE PACEMAKER SHOWED APPROPRIATE FUNCTION. THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYMMETRY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5360 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |