FDA Adverse Event
Injury
Summary report: N
ADVISA DR MRI SURESCAN
MDR report key: 3991225
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14324
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 2, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. CONCOMITANT PRODUCT: 5086MRI52 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, ONE DAY POST IMPLANT, THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A DROPPED VENTRICULAR PACE FOLLOWING AN ATRIAL SENSE. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467470 | ADVISA DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | A2DR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Required Intervention | 5086MRI58 LEAD |