FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE VR, DF-4 CONNECTOR
MDR report key: 4031733
·
Received August 22, 2014
Report
- Report Number
- 2938836-2014-14764
- Event Type
- Malfunction
- Date Received
- August 22, 2014
- Date of Event
- June 4, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
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 ANOMALY WAS FOUND. THE CAUSE OF THE EXTENDED CHARGE TIME WAS AN INTERNAL HV CAPACITOR ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT, A LONG CHARGE TIME ALERT WAS OBSERVED WHILE THE DEVICE WAS STILL IN THE BOX. THE DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 509743 | ELLIPSE VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1411-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |