FDA Adverse Event
Other
Summary report: N
SPRING QUATTRO SECURE MRI SURESCAN LEAD
MDR report key: 22796176
·
Received August 13, 2025
Report
- Report Number
- MW5174447
- Event Type
- Other
- Date Received
- August 13, 2025
- Date of Event
- July 11, 2025
- Report Date
- August 1, 2025
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVY
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO EXPERIENCING SYNCOPE. UPON EXAMINATION OF THE ELECTROGRAMS (EGMS), THERE WERE EPISODES OF NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WERE ALSO EPISODES OF LOSS OF RV CAPTURE, SMALL R-WAVES, LOW PACING LEAD IMPEDANCE, LOW HIGH VOLTAGE LEAD IMPEDANCE, AND EPISODES OF CROSSTALK INDICATIVE OF RV LEAD FAILURE. ADDITIONAL LEAD TESTING OR LEAD REVISION WAS RECOMMENDED. THERE WAS NO FURTHER ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782273 | SPRING QUATTRO SECURE MRI SURESCAN LEAD | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MEDTRONIC, INC. | 6947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |