FDA Adverse Event
Malfunction
Summary report: N
LD CV EZTRK 2 BP IS1 4543 90CM US
MDR report key: 605138
·
Received November 9, 2004
Report
- Report Number
- 2124215-2004-08861
- Event Type
- Malfunction
- Date Received
- November 9, 2004
- Date of Event
- September 24, 2004
- Report Date
- September 24, 2004
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- NIK
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS LEFT VENTRICULAR LEAD, THE IMPEDANCE MEASUREMENTS TAKEN THROUGH A MEDTRONIC PACING SYSTEM ANALYZER (PSA) WAS VERY HIGH. WHEN THE LEAD WAS CONNECTED TO THE PACEMAKER, THE IMPEDANCE WAS NA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD CV EZTRK 2 BP IS1 4543 90CM US | IMPLANTABLE LEAD | NIK | CARDIAC PACEMAKERS | 4543 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |