FDA Adverse Event
Injury
Summary report: N
TRILOGY DR+
MDR report key: 1050607
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01574
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 3, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- 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 PRESENTED IN FULL CODE IN THE EMERGENCY ROOM, AND DEVICE TELEMETRY COULD NOT BE ESTABLISHED. IN MAY 2007 THE ESTIMATED LONGEVITY WAS TWO MONTHS. THE PATIENT WAS THEN PUT ON MONTHLY FOLLOW-UPS. ONE MONTH PRIOR TO THE EVENT, THE PATIENT HAD A MAGNET RATE OF 70 PPM, THE SAME AS THE PREVIOUSLY PROGRAMMED BASE RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY DR+ | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2360L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |