FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 4153500
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16383
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 29, 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 Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF EXTENDED 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 OBSERVED ONE OF THE HV CAPACITORS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED VIBRATORY NOTIFICATION FOR CAPACITOR CHARGE TIME LIMIT REACHED. A MANUAL CAPACITOR MAINTENANCE PERFORMED IN CLINIC WAS UNSUCCESSFUL. DEVICE WAS EXPLANTED. PATIENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630476 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2377-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |