FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1222966
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03255
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 18, 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
- NJ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD MEASURED VARYING P-WAVE VALUES WHEN THE PATIENT STOOD UP AND WHEN SHE SAT DOWN. THE SIGNAL AMPLITUDE RANGED FROM 2.5 MV TO LESS THAN 1 MV. THE PACING LEAD IMPEDANCE HAD CONSISTENTLY BEEN AROUND 450 OHMS. CAPTURE THRESHOLD HAD BEEN APPROXIMATELY 0.75 V TO 1.25 V.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1388TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |