FDA Adverse Event
Malfunction
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1679635
·
Received May 11, 2010
Report
- Report Number
- 2017865-2010-02051
- Event Type
- Malfunction
- Date Received
- May 11, 2010
- Date of Event
- January 22, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FAILURE OBSERVED DURING THE ASSOCIATED ICD ANALYSIS. IT IS SUSPECTED THAT THE LEAD MIGHT HAVE SHORTED CAUSING A LOW IMPEDANCE PATH AND TRIGGERED THE POSSIBLE HIGH VOLTAGE LEAD ISSUE ALERT. THE LEAD REMAINS IMPLANTED.
Description of Event or Problem · 1
DURING DFT TESTING, THE PATIENT WAS INDUCED BUT WAS UNABLE TO BE RESCUED TWICE BY THE DEVICE. BOTH TIMES, THE PATIENT WAS RESCUED BY EXTERNAL DEFIB. AFTER THE SECOND EXTERNAL DEFIB, THE REP WAS UNABLE TO ACCESS THE FIBBER AND NONINVASIVE PROGRAMMED STIMULATION TEST SCREEN, DUE TO EXCESSIVE CHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7021/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |