FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1830421
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03212
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- July 7, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- 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
IT WAS REPORTED THAT THE PATIENT HAD SEVERAL ABORTED VF EPISODES. REVIEW OF THE EGMS SHOWED NOISE ON THE LEAD. RECOMMENDED A CHEST X-RAY, ISOMETRICS AND POSITIONAL TESTING. THE PHYSICIAN OPTED TO MONITOR THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |