FDA Adverse Event
Malfunction
Summary report: N
REVO MRI SURESCAN
MDR report key: 2811447
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06179
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT, THE DEVICE BATTERY VOLTAGE WAS CHECKED AS THE PRODUCT WAS CLOSE TO THE EXPIRATION DATE. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVO MRI SURESCAN | IMPLANTABLE PULSE GENERATOR | LWP | MEDTRONIC MED REL, INC. | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |