FDA Adverse Event
Injury
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 3920926
·
Received July 8, 2014
Report
- Report Number
- 2938836-2014-13329
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- April 25, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 REPORTED THAT THE PATIENT WAS PRESENTED IN EMERGENCY ROOM AFTER RECEIVING SEVERAL INAPPROPRIATE ATP AND HV THERAPIES DUE TO OVERSENSING OF NOISE. THE PATIENT HAD BEEN IMPLANTED WITH BOTH A PACEMAKER AND ICD. THE DEVICE WAS DOUBLE-COUNTING THE PACED EVENTS FROM THE PACEMAKER. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION AFTER THE EVENT WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398372 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1411-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |