FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 3791202
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10435
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- February 18, 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
- IL, US
- Reporter Occupation
- PHYSICIAN
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 PRESENTED IN THE HOSPITAL AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPIES DUE TO NOISE. THE LEAD EXHIBITED ELEVATED PACING THRESHOLDS, AND IMAGING OF THE LEAD REVEALED A FRACTURE. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268467 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |