FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1955680
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00881
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 17, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- 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 VENTRICULAR LEAD EXHIBITED HIGH BIPOLAR THRESHOLD AT 3.75 V. WHEN A MANUAL CAPTURE THRESHOLD TEST WAS PERFORMED, THRESHOLD WAS FOUND TO BE 5.5 V AT 1.0 MS. TESTING THE LEAD IN UNIPOLAR WAS ATTEMPTED, HOWEVER THE PATIENT EXPERIENCED DISCOMFORT DUE TO POCKET STIMULATION. THE LEAD WAS SUCCESSFULLY REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1888TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |