FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4030765
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14685
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- July 22, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 NOTED THAT DURING NORMAL DEVICE CHANGE OUT, LEAD FRACTURE WAS SUSPECTED. AFTER THE CHRONIC LEAD WAS CONNECTED TO THE NEW DEVICE, A SUCCESSFUL DFT WAS PERFORMED. HOWEVER, RETURNED TO SINUS WAS NOT DETECTED. THE DEVICE CHARGED TO DELIVER A SECOND SHOCK, HOWEVER LOW, OUT OF RANGE HV LEAD IMPEDANCE WAS OBSERVED. THE LEAD WAS CAPPED AND REPLACED. IT WAS NOTED THAT THERE WAS DAMAGE MADE TO THE LEAD DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509292 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1591/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |