FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4130887
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16216
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- September 15, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED IN THE HOSPITAL AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO LEAD NOISE. AN ALERT FOR LOW, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607878 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |