FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1223892
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03416
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- September 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE COULD BE SEEN ON THE ELECTROGRAM AND AUTOMATIC MODE SWITCH (AMS) EPISODES WERE OBSERVED, BUT WITHOUT A FAST ATRIAL RATE. IMPEDANCE HAD DECREASED FROM 520 OHMS TO 340 OHMS. NOISE WAS OBSERVED DURING ISOMETRIC TESTING, AND IMPEDANCE DROPPED TO 130 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |