FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE ST DR
MDR report key: 4130720
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16229
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- July 31, 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 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 DURING DEVICE INTERROGATION, AN ALERT FOR NON-SUSTAINED LEAD NOISE WAS OBSERVED. REVIEW OF THE EPISODES INDICATED INTERMITTENT POST-PACED T-WAVE OVERSENSING. THE ISSUE WAS AN ISOLATED INCIDENT, AND NO ACTION WILL BE TAKEN AT THIS TIME. THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WILL BE MONITORED VIA MERLIN.NET
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607939 | ELLIPSE ST DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2277-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7002/65, ABH10448 |