FDA Adverse Event
Malfunction
Summary report: N
REVO MRI SURESCAN
MDR report key: 2813187
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06471
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 9, 2012
- Report Date
- February 8, 2013
- 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
EVALUATION SUMMARY: (B)(4) UPON ANALYSIS, NO ANOMALIES FOUND.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE, THE DEVICE BATTERY VOLTAGE WAS CHECKED AND FOUND TO BE BELOW ELECTIVE REPLACEMENT INDICATOR (ERI). THE VOLTAGE WAS LATER CHECKED AND STILL HAD NOT RETURNED TO NOMINAL SETTINGS. THE DEVICE WAS NOT USED FOR ANY IMPLANT AND THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MED REL, INC. | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |