FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 2952442
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01715
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- September 12, 2012
- Report Date
- November 13, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY #(B)(4) - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S LEAD WERE INFECTED. THE ECHOCARDIOGRAM SHOWED VEGETATION ON THE LEAD AND AN ELEVATED WHITE BLOOD COUNT. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55632 | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R | 5086MRI X 2 IMPLANTABLE PACING LEADS |