FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR ICD
MDR report key: 8408834
·
Received March 11, 2019
Report
- Report Number
- 2017865-2019-03558
- Event Type
- Malfunction
- Date Received
- March 11, 2019
- Date of Event
- March 2, 2019
- Report Date
- March 11, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVZ
- UDI-DI
- 05414734506113
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT RECEIVED VIBRATORY ALERTS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE DEVICE WAS MISINTERPRETING PREMATURE VENTRICULAR CONTRACTIONS AS NUN SUSTAINED RIGHT VENTRICULAR OVER-SENSING. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE THROUGHOUT EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200529 | ELLIPSE VR ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NVZ | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD1311-36Q | 4092625 | 05414734506113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |