FDA Adverse Event
Malfunction
Summary report: N
QUICKSITE LV
MDR report key: 1223838
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03442
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- September 29, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ONLY THE PROXIMAL PORTION OF THE THE WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED IMPEDANCES RANGING FROM 190 TO 650 OHMS. A CHEST X-RAY WAS TAKEN AND SHOWED NO IRREGULARITIES. THE LEAD WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICKSITE LV | PERMANENT PACEMAKER ELECTRODE | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1056T/86 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |