FDA Adverse Event
Injury
Summary report: N
ELLIPSE ST DR, DF-4 CONNECTOR
MDR report key: 4210689
·
Received October 29, 2014
Report
- Report Number
- 2938836-2014-17205
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- September 3, 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
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF LONG CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND AN INTERNAL HV CAPACITOR ANOMALY WAS FOUND. THE CAUSE OF THE LONG CHARGE TIME WAS AN INTERNAL HV CAPACITOR ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, TWO CONSECUTIVE CAPACITOR MAINTENANCES RESULTED IN EXTENDED CHARGE TIMES. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO COMPLICATIONS OR ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692851 | 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 | Required Intervention |