FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223503
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03617
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE AND THE R-WAVE AMPLITUDE VARIED. THE CAPTURE THRESHOLD AND IMPEDANCE HAD INCREASED. THE NOISE WAS NOT OVERSENSED AND DID NOT INHIBIT PACING. THEREFORE, INAPPROPRIATE THERAPY WAS NOT DELIVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |