FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR ICD
MDR report key: 4840503
·
Received June 12, 2015
Report
- Report Number
- 2938836-2015-26939
- Event Type
- Malfunction
- Date Received
- June 12, 2015
- Date of Event
- April 17, 2015
- Report Date
- April 17, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS OBSERVED ON A STORED EGM. PROGRAMMING CHANGES WERE MADE AND DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT AN INCIDENT OF POST-PACED T-WAVE OVERSENSING WAS OBSERVED AGAIN. ADDITIONAL PROGRAMMING CHANGES WERE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386126 | ELLIPSE DR ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2311-36Q | 4091640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |