FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1830496
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03446
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- November 24, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- 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
DURING A FOLLOW-UP, IT WAS NOTED THAT THE R-WAVES HAD DECREASED OVERTIME AND NOISE WAS ALSO OBSERVED. WHEN THE SENSITIVITY WAS CHANGED, THE R-WAVES DROPPED. DURING THE SURGICAL PROCEDURE, IT WAS FOUND THAT THE PATIENT HAD A PRE-EXISTING PACE/SENSE LEAD THAT WAS CAPPED. THE LEAD WAS UNCAPPED AND PLUGGED INTO THE ICD PACE/SENSE PORT. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED. THE DEFIB PORTION OF LEAD REMAINS ACTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |