FDA Adverse Event
Injury
Summary report: N
REGENCY SC
MDR report key: 1904436
·
Received November 22, 2010
Report
- Report Number
- 2017865-2010-05248
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- September 15, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880006
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- 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 THE PATIENT FAINTED AND WAS ADMITTED TO ACCIDENT AND EMERGENCY. THE PATIENT HAD LOSS OF VENTRICULAR CAPTURE AND HENCE WENT INTO PAUSE DEPENDENT VENTRICULAR FIBRILLATION. INTERROGATION OF THE PULSE GENERATOR SHOWED A SUDDEN INCREASE OF THRESHOLD TO 2.7 V. THE PATIENT UNDER- WENT LUNG SURGERY THREE MONTHS PRIOR WHERE DIATHERMY WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REGENCY SC | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2406L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |