FDA Adverse Event
Injury
Summary report: N
REVO MRI SURESCAN
MDR report key: 3992598
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14796
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 18, 2014
- Report Date
- June 18, 2014
- 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
- MD, 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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A FULL ELECTRICAL RESET.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE 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 COMPLAINED OF PACEMAKER SYNDROME AND THE DEVICE WAS FOUND TO HAVE AN ELECTRICAL RESET. THE DEVICE WAS REPROGRAMMED AND REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 469999 | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | RVDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Required Intervention | 5086MRI X2 LEADS |