FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 1073319
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02113
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 9, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- 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 PATIENT HAD SEVERAL PAUSES IN THE BIPOLAR CONFIGURATION. NO NOISE WAS SEEN ON THE INTRACARDIAC ELECTROGRAM BUT OVERSENSING AND LOW LEAD IMPEDANCE WERE CONFIRMED. ISOMETRICS AND POCKET MANIPULATION COULD NOT REPRODUCE PAUSES. THIS WAS RESOLVED BY CHANGING THE VENTRICULAR POLARITY TO THE UNIPOLAR CONFIGURATION.
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 | 1388T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |