FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 3160380
·
Received June 10, 2013
Report
- Report Number
- 3004209178-2013-10095
- Event Type
- Injury
- Date Received
- June 10, 2013
- Report Date
- March 22, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWP
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND.
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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. THE IPG SYSTEM WAS REPLACED A MONTH LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259963 | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Hospitalization| R | 5086M X2 IMPLANTABLE PACING LEAD |