FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE ST DR, DF-4 CONNECTOR
MDR report key: 4153470
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16375
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- August 11, 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
- GB
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT LEAD DETAILS WERE NOT ENTERED AT IMPLANT. DURING DFTS, THE DEVICE RESPONDED THAT THE LEAD WAS DUAL COIL. THE DEVICE WAS PROGRAMMED TO RV-CAN ONLY. THE PHYSICIAN THEN ENTERED THE LEAD DETAILS, AND A MESSAGE APPEARED ASKING TO CLEAR DATA. REPROGRAMMING THE DEVICE TO PREVIOUS SETTINGS RESOLVED THE ISSUE. THE PATIENT WAS NOT AFFECTED BY THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630455 | ELLIPSE ST DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2277-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |