FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
MDR report key: 17527012
·
Received August 12, 2023
Report
- Report Number
- MW5133948
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- February 7, 2021
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS OVERSENSING OF THE RESPIRATORY SENSOR SIGNAL ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE RESPIRATORY RATE TREND FEATURE WAS TURNED OFF AND ADDITIONAL NOISE WAS SUBSEQUENTLY PRESENT. THE RV PACE IMPEDANCE HAD BEEN IN THE UPPER 200 OHM RANGE; HOWEVER, SPIKES IN IMPEDANCE WERE OBSERVED IN THE 800-900 OHMS RANGE. THE RV LEAD REMAINS IN SERVICE AT THIS TIME AND NO ADVERSE PATIENT EFFECTS WERE REPORTED 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 |
|---|---|---|---|---|---|---|---|
| 597403 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MEDTRONIC | 6947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |