FDA Adverse Event
Injury
Summary report: N
ACCENT DR RF
MDR report key: 2240146
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05972
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 1, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT THE BATTERY WAS HEAVILY DEPLETED DUE TO A DEFECTIVE ZARLINK CHIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING SYNCOPE. THE PATIENT HAD AN INTRINSIC HEART RHYTHM OF 30 BEATS PER MINUTE. THE PULSE GENERATOR EXHIBITED LOSS OF OUTPUT, SENSING, CAPTURE AND TELEMETRY ANOMALIES. THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |