FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR, DF-4 CONNECTOR
MDR report key: 3943823
·
Received July 18, 2014
Report
- Report Number
- 2938836-2014-13483
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 20, 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
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MERLIN.NET STOPPED TRANSMITTING REMOTE FOLLOW-UPS. AT THE IN-CLINIC FOLLOW-UP IT WAS DETERMINED THAT THE RF TELEMETRY WAS NOT FUNCTIONING. REMOTE MONITORING WILL CONTINUE WITH INDUCTIVE TELEMETRY. PATIENT DID NOT EXPERIENCE ADVERSE EVENTS CAUSED BY THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421432 | ELLIPSE DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |