FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 2810873
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06164
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- March 12, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- 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 DURING A CLINIC VISIT, THE RESET WAS FOUND WHEN SEEING PATIENT POST RADIATION TREATMENT. THE DEVICE WAS REPROGRAMMED 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 |
|---|---|---|---|---|---|---|---|
| 1 | REVO MRI SURESCAN | IMPLANTABLE PULSE GENERATOR | LWP | MEDTRONIC MED REL, INC. | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | (B)(4) X2 IMPLANTABLE PACING LEADS |