FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 3854657
·
Received June 6, 2014
Report
- Report Number
- 2938836-2014-11477
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- April 15, 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 AN HV CHARGE TIMEOUT WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND ANOMALOUS CAPACITORS WERE FOUND. THE ROOT CAUSE OF THE EXTENDED CHARGE TIME WAS ANOMALOUS CAPACITORS.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT, A MESSAGE STATING CHARGE TIME LIMIT REACHED WAS OBSERVED. DEVICE WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330911 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2411-36C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |