FDA Adverse Event
Malfunction
Summary report: N
RV LEAD
MDR report key: 17536068
·
Received August 12, 2023
Report
- Report Number
- MW5142960
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 20, 2022
- Manufacturer
- UNKNOWN
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
COMPLAINT NOTES: REP WAS WITH PT DURING CALL, DID NOT ASK WEIGHT. SEE ATTACHED. PATIENT HAD ALERTS FOR RVT-RVR IMPEDANCE > 3000 OHMS. TTR IMPEDANCE WAS TRENDING AT ... 1500 OHMS AND HAD A SUDDEN JUMP TO> 3000 OHMS. CLEAR EVIDENCE OF RVR FAILURE OR CONNECTION ISSUE AS RVT-RVC IMPEDANCE HAS REMAINED STABLE. DISCUSSED RV PACING IMPEDANCE ALERT FUNCTIONALITY. DISCUSSED SINCE THIS WAS RECENT GEN CHANGE COULD BE A CONNECTION ISSUE. DISCUSSED IF THIS W ERE A CONNECTION AND RVT ELECTRODE CONNECTION BECOMES COMPROMISED THERE MAU BE OS THAT COULD INHIBIT PACING. 604791915. 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 |
|---|---|---|---|---|---|---|---|
| 1073286 | RV LEAD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | UNKNOWN | 7120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |