FDA Adverse Event
Injury
Summary report: N
TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA
MDR report key: 705956
·
Received April 27, 2006
Report
- Report Number
- 2938836-2006-00333
- Event Type
- Injury
- Date Received
- April 27, 2006
- Date of Event
- March 21, 2006
- Report Date
- April 1, 2006
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE ST. JUDE MEDICAL REPRESENTATIVE REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AS A RESULT OF OVERSEEING. TECHNICAL SERVICES DISCUSSED THERE WAS R-WAVE VARIABILITY RESULTING IN SOME INSTANCES OF UNDERSENSING. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA | TRANSVENOUS DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL, INC., CRMD | 1559/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |