FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM
MDR report key: 1050721
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01678
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 FAR P OVERSENSING WAS OBSERVED ON THE EGMS. TTS DISCUSSED PROGRAMMING OPTIONS. A DECREASE IN R-WAVES WAS ALSO NOTED. TTS ALSO DISCUSSED CHEST X-RAYS AND ISOMETRIC TESTING TO EVALUATE LEAD DISLODGMENT. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |