FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM PASSIVE FIXATION
MDR report key: 4021881
·
Received August 19, 2014
Report
- Report Number
- 2938836-2014-14427
- Event Type
- Injury
- Date Received
- August 19, 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 RECEIVED A PATIENT NOTIFICATION FOR VENTRICULAR OVERSENSING. REVIEWED OF THE DATA SHOWED LEAD NOISE. LEAD DAMAGE IS SUSPECTED. REMOTE MONITORING AND IN-CLINIC FOLLOW-UP ARE PLANNED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS CAPPED AND REPLACED. PATIENT CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500041 | RIATA ST OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7070/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |