FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION
MDR report key: 2984303
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00522
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- December 11, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 DURING PATIENT FOLLOW-UP, HIGH CAPTURE THRESHOLD AND DECREASED SENSING WERE REPORTED. FLUOROSCOPY REVEALED THAT THE LEAD HAD PULLED BACK SLIGHTLY. DURING THE EXPLANT PROCEDURE, THE MD USED A FIRM STYLET, NOTICED THAT THE LEAD HAD BROKEN OFF AT THE TIP. THE REST OF THE LEAD WAS EXPLANTED AND REPLACED. THE TIP REMAINS ATTACHED TO THE VENTRICLE. THE PATIENT IS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86425 | DURATA STS OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7170/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |