FDA Adverse Event
Malfunction
Summary report: N
REVO MRI SURESCAN
MDR report key: 3990652
·
Received August 8, 2014
Report
- Report Number
- 9614453-2014-01772
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 12, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
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. CONCOMITANT CONTINUED: 5086MRI52 LEAD, IMPLANTED 2011-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INTERROGATION OF THE DEVICE DID NOT DISPLAY THE BATTERY VOLTAGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
THE PATIENT WAS UNDERGOING RADIATION THERAPY, WHICH CAUSED A DISRUPTION IN DEVICE MEMORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472682 | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | IPG MFG SWITZERLAND | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | 5086MRI45 LEAD |