FDA Adverse Event
Malfunction
Summary report: N
ADVISA DR MRI SURESCAN
MDR report key: 4152898
·
Received October 8, 2014
Report
- Report Number
- 3004209178-2014-18511
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 9, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TELEMETRY STRIPS INDICATE A LOWER RATE THAN THE DEVICES PROGRAMMED LOWER RATE. THE DEVICE IS PROGRAMMED FOR ATRIAL PACING. TECHNICAL REVIEW OF THE PROVIDED STRIPS NOTED THAT OVERSENSING OF THE QRS OR THE T-WAVE WAS OBSERVED. THE DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 630954 | ADVISA DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC PUERTO RICO OPERATIONS CO. | A2DR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00010 YR |