FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1073402
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02191
- 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
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 THE ATRIAL LEAD EXHIBITED GREATER THAN 2500 OHMS IMPEDANCE IN THE BIPOLAR CONFIGURATION. THE PATIENT HAD NO COMPLAINTS. THE DEVICE WOULD BE PROGRAMMED TO THE UNIPOLAR CONFIGURATION. THE PATIENT WOULD BE FOLLOWED-UP IN TWO MONTHS.
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/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |