FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 4153613
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16513
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- August 25, 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
- OTHER
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 CLINIC AFTER RECEIVING A VIBRATORY ALERT FOR HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE. THE IMPEDANCE HAD BEEN GRADUALLY INCREASING. FURTHER TESTING WAS RECOMMENDED. A LEAD REVISION WILL BE CONSIDERED WHEN THE DEVICE REACHES ERI.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN GREAT CONDITION POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631467 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |