FDA Adverse Event
Malfunction
Summary report: N
EPIC HF CRT-D
MDR report key: 1050646
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01608
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- May 31, 2006
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SVT. THE CASE WAS CLINICALLY RESOLVED BY REPROGRAMMING THE DEVICE TO DEFIB ONLY AT 222 BPM; THEREFORE, THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC HF CRT-D | NO BNCN FOUND FOR THIS DEVICE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-337 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |