FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1955573
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00707
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 5, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF POCKET STIMULATION. MUSCLE STIMULATION COULD BE REPRODUCED BY PACING IN THE ATRIUM. NOISE WAS OBSERVED ON THE ATRIAL CHANNEL WHEN PERFORMING ISOMETRICS. THE PATIENT DEMONSTRATED TWIDDLER'S SYNDROME.
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 | 44 YR |