FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 1073404
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02193
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE ASYMPTOMATIC PATIENT PRESENTED IN THE CLINIC FOR A ROUTINE FOLLOW-UP. AT IMPLANT THE LEAD IMPEDANCE WAS 750 OHMS BUT WAS 207 OHMS AT THE FOLLOW-UP. CAPTURE THRESHOLDS HAD INCREASED FROM 0.8 V TO 2.2 V.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |