FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1895684
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04509
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 5, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 SENSING THRESHOLDS HAD DECREASED AND THE CAPTURE THRESHOLD HAD INCREASED. THE LEAD WAS FOUND TO BE DISLODGED. THE MORPHOLOGY OF THE ICD WAS PROGRAMMED TO PASSIVE TO SEE IF THE SITUATION STABILIZED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT AT THE SUBSEQUENT FOLLOW-UP VISIT, CHEST X-RAY SHOWED NO SIGNS OF DISLODGEMENT AND THE THRESHOLDS HAD STABILIZED. THE PHYSICIAN HAD NO FURTHER CONCERNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |