FDA Adverse Event
Malfunction
Summary report: N
CURRENT DR RF
MDR report key: 4021792
·
Received August 19, 2014
Report
- Report Number
- 2938836-2014-14438
- Event Type
- Malfunction
- Date Received
- August 19, 2014
- Date of Event
- June 4, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION IDENTIFIED SILICONE, SEPTUM MATERIAL INSIDE THE ATRIAL AND VENTRICULAR SENSE/PACE SET SCREW CAVITIES. THIS MATERIAL PREVENTED FULL INSERTION OF THE TORQUE DRIVER IN THE HEX CAVITIES AND RESULTED IN DIFFICULTY LOOSENING THE SET SCREWS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING NORMAL DEVICE CHANGE OUT IT WAS DIFFICULT TO LOOSEN THE SET SCREW. THE PATIENTS CONDITION WAS FINE AND STABLE THROUGHOUT THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499408 | CURRENT DR RF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |