FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS DR, DF-4 CONNECTOR
MDR report key: 3910957
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-13001
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- February 18, 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
- SE
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WENT INTO SOFTWARE RESET MODE. ALL THE PARAMETERS ON THE DEVICE WERE NORMAL. UPON RE-INTERROGATION OF THE DEVICE, THE SOFTWARE RESET ALERT WAS STILL PRESENT. A SUCCESSFUL DEVICE DOWNLOAD WAS LATER PERFORMED, AND THE DEVICE WAS RESTORED TO NORMAL OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387022 | CURRENT PLUS DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |