FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR
MDR report key: 7958710
·
Received October 11, 2018
Report
- Report Number
- 2938836-2018-11302
- Event Type
- Injury
- Date Received
- October 11, 2018
- Date of Event
- October 1, 2018
- Report Date
- October 11, 2018
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- UDI-DI
- 05414734507615
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY AFTER MULTIPLE SUPRAVENTRICULAR TACHYCARDIA (SVT) DIAGNOSIS DUE TO P - WAVES BEING BLANKED BY R WAVES. PROGRAMMING CHANGES WERE SUGGESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797659 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2411-36Q | S000043516 | 05414734507615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |