FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 3953179
·
Received July 23, 2014
Report
- Report Number
- 2938836-2014-13594
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 11, 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
- NH, 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 INAPPROPRIATE NON-SUSTAINED RV OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION. IT WAS NOTED THAT THE P-WAVES WERE FALLING INTO POST-VENTRICULAR ATRIAL REFECTORY (PVARP), LEADING TO ATRIAL AND VENTRICULAR PACED EVENTS. NO PATIENT SYMPTOMS WERE REPORTED. PROGRAMMING CHANGES WERE MADE.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT ANOTHER INSTANCE OF INAPPROPRIATE NON-SUSTAINED RV OVERSENSING WAS OBSERVED. IT WAS NOTED THAT THE P-WAVES WERE FALLING INTO POST-VENTRICULAR ATRIAL REFECTORY (PVARP), LEADING TO ATRIAL AND VENTRICULAR PACED EVENTS. PROGRAMMING CHANGES WERE RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431559 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2411-36C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |