FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 4220961
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17457
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- August 4, 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
- AU
- 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 PATIENT RECEIVED A VIBRATORY ALERT AND PRESENTED TO THE CLINIC. NON-SUSTAINED LEAD NOISE EPISODES DUE TO CROSSTALK WERE OBSERVED. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS STABLE AFTER THE EVENT. FOLLOW-UP WILL CONTINUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702520 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2377-36C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | (B)(4) |