FDA Adverse Event
Injury
Summary report: N
ADVISA DR MRI SURESCAN
MDR report key: 3861811
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11150
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- April 8, 2014
- Report Date
- April 8, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- 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. PRODUCTS: (B)(4) LEAD IMPLANTED: 2014 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, ONE WEEK POST IMPLANT, THAT THE PATIENT SUFFERED A STROKE. THE PATIENT WAS IMPLANTED WITH AN MRI SYSTEM AND THERE WAS AN INQUIRY WHETHER THEY COULD HAVE AN MRI PERFORMED. THE IMPLANTABLE PULSE GENERATOR (IPG) 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 |
|---|---|---|---|---|---|---|---|
| 341472 | ADVISA DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC PUERTO RICO OPERATIONS CO. | A2DR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Life Threatening | (B)(4) LEAD |