FDA Adverse Event
Malfunction
Summary report: N
REVO MRI SURESCAN
MDR report key: 2130761
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03394
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 THE PATIENT WAS FEELING DIZZY. NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE CLINIC. 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | (B)(4) IMPLANTABLE PACING LEAD |