FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1073367
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02156
- 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
- AZ
- 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
THE PATIENT PRESENTED TO THE PHYSICIAN'S OFFICE WITH LIGHT HEADEDNESS WHEN SITTING OR STANDING UPRIGHT. DURING EXERCISE MOVEMENTS NOISE WAS REPRODUCED ON THE EGM. THE PULSE GENERATOR WOULD BE LEFT AS PROGRAMMED. THE PATIENT WOULD BE MONITORED.
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 | 1488T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |