FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 2240497
·
Received September 9, 2011
Report
- Report Number
- 2017865-2011-05657
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- June 4, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- 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
IT WAS REPORTED THAT (B)(4) TRIGGERED AN ALERT FOR ATRIAL LEAD IMPEDANCE LESS THAN 200 OHMS. IN OFFICE, LOW IMPEDANCE COULD NOT BE REPRODUCED WITH EXTERNAL MANIPULATION OF THE DEVICE. HOWEVER, ATRIAL NOISE WAS PRODUCED ON THE ATRIAL CHANNEL. LEAD REVISION WAS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |