FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 3944025
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13436
- Event Type
- Injury
- Date Received
- July 18, 2014
- Date of Event
- June 5, 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
- IT
- 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 FOR A FOLLOW UP. UPON INTERROGATION, AN ALERT FOR HIGH PACING LEAD IMPEDANCE, INCREASED THRESHOLD AND DECREASE IN SENSING WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS GOOD AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422985 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |