FDA Adverse Event
Injury
Summary report: N
TRILOGY DR+
MDR report key: 152589
·
Received February 6, 1998
Report
- Report Number
- 2017865-1998-00111
- Event Type
- Injury
- Date Received
- February 6, 1998
- Date of Event
- October 26, 1997
- Report Date
- September 30, 1997
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H9 - FINAL ANALYSIS - NO OUTPUT OR TELEMETRY; MECHANISM - CRYSTAL ANOMALY; COMPONENT - CRYSTAL.
Description of Event or Problem · 1
INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DEVICE EXH IBITED NO PACING DURING ECG MONITORING AND WITH MAGNET APPLICATION. ATTEMPTED PROGRAMMING NOTED NOO TELEMETRY AND NO RESPONSE TO MAGNET APPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY DR+ Implant | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2360L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |