FDA Adverse Event
Injury
Summary report: N
MARQUIS
MDR report key: 2955166
·
Received February 11, 2013
Report
- Report Number
- 9614453-2013-00169
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- November 8, 2012
- Report Date
- November 12, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE AND ANALYZED. A POWER ON RESET (POR) OCCURED FOR WRITE TO LOCKED RANDOM ACCESS MEMORY ON (B)(6) 2012. THERE WAS ONE PATIENT ALERT FOR POR ON (B)(6) 2012. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A POWER ON RESET OCCURRED ON THE DEVICE. THE DEVICE WAS RESET AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57975 | MARQUIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | 7230CX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |