FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 2810847
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06283
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 BY THE PATIENT THAT THE PATIENT "PASSED OUT". ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED, HOWEVER, IT WAS NOT AVAILABLE. THE DEVICE IS STILL IN USE. NO FURTHER 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 | 51 YR | Life Threatening| O | (B)(4) X2 IMPLANTABLE PACING LEADS |