FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 4210699
·
Received October 29, 2014
Report
- Report Number
- 2938836-2014-17244
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- August 13, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALY WAS FOUND. THE HV CAPACITORS WERE RETURNED TO THEIR MANUFACTURING SITE FOR FURTHER ANALYSIS AND NO ANOMALY WAS FOUND. THE CAUSE OF THE EXTENDED CHARGE TIME COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A NORMAL FOLLOW UP, EXTENDED CHARGE TIME WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693695 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2377-36QC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |