FDA Adverse Event
Injury
Summary report: N
CADENCE V-110C
MDR report key: 231140
·
Received July 9, 1999
Report
- Report Number
- 231140
- Event Type
- Injury
- Date Received
- July 9, 1999
- Date of Event
- June 1, 1999
- Report Date
- July 9, 1999
- Manufacturer
- VENTRITEX
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT PRESENTED TO DEFIBRILLATOR CLINIC ON 06/01/1999 PACEMAKER WAS PROGRAMMED TO "WI" RATE OF 40, PACING WAS DOCUMENTED VIA EKG AT APPROX 117 BPM. DEVICE COULD NOT BE INTERROGATED. ICD REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADENCE V-110C Implant | ICD | LWS | VENTRITEX | V-110C | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| R |