FDA Adverse Event
Injury
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 4130744
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16223
- Event Type
- Injury
- Date Received
- September 30, 2014
- Date of Event
- September 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING A VIBRATORY PATIENT NOTIFIER. UPON INTERROGATION, AN ALERT FOR LONG CHARGE TIME LIMIT EXCEEDED WAS OBSERVED. THE CAPACITOR MAINTENANCE RESULTED IN A LONGER CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT IS DOING GREAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607992 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |