FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 3892707
·
Received June 24, 2014
Report
- Report Number
- 2938836-2014-12394
- Event Type
- Injury
- Date Received
- June 24, 2014
- Date of Event
- April 11, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE POCKET WAS CAUSING PAIN TO THE PATIENT DUE TO AN INFLAMMATORY RESPONSE TO THE DEVICE. THE SYSTEM WAS EXPLANTED AND WAS NOT REPLACED. NO ADVERSE EVENTS OCCURRED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369075 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | 7122Q/58,(B)(4) |