FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 2791673
·
Received October 15, 2012
Report
- Report Number
- 6000144-2012-05444
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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'S INTRAVENOUS ACCESS FOR PARENTERAL NUTRITION BECAME INFECTED LEADING TO VEGETATION ON THE LEADS AND ENDOCARDITIS. THE DEVICE AND LEADS WERE EXPLANTED AND NOT REPLACED. THE DEVICE AND LEADS WILL NOT BE RETURNED. THE PATIENT WAS A PARTICIPANT IN THE SYSTEMS LONGEVITY STUDY. NO FURTHER PATIENT COMPLICATIONS WERE 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 | 44 YR | Hospitalization| R |