FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 2953221
·
Received February 9, 2013
Report
- Report Number
- 9614453-2013-00206
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 21, 2012
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO (B)(4) INFECTION. A NEW SYSTEM HAS SINCE BEEN IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55760 | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | IPG MFG SWITZERLAND | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 5086MRI X 2 IMPLANTABLE PACING LEADS |