FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE ST VR, DF-4 CONNECTOR
MDR report key: 4210700
·
Received October 29, 2014
Report
- Report Number
- 2938836-2014-17202
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Date of Event
- September 19, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 DURING MANUAL CAPACITOR MAINTENANCE CHECKS, FLUCTUATING CHARGE TIMES WERE OBSERVED. OVERSENSING OF WIDE QRS WAS NOTED UPON THE INITIALIZATION OF THE CHARGE, RESULTING IN THE TERMINATION OF THE CHARGING. NO ACTION WAS TAKEN AT THIS TIME. PATIENT CONDITION WAS FINE AND WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693931 | ELLIPSE ST VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1277-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |