FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3090071
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01111
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- March 1, 2013
- 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 Location
- NY
- 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
NEW INFORMATION RECEIVED NOTES THE LEAD WAS CAPPED AND REPLACED. THE PATIENT CONDITION IS GOOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR FOLLOW UP. REVIEW OF SESSION RECORDS SHOWED HIGH IMPEDANCE. IT WAS NOTED THAT THE PATIENT HAD RECENTLY UNDERWENT SEVERAL DIALYSIS TREATMENTS. THE LEAD WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191005 | 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 | 77 YR | Required Intervention |