FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1896252
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05089
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- August 17, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 LEAD EXHIBITED INTERMITTENT CAPTURE WITH HIGH THRESHOLD OF 5.5 V AT 1.0 MS AND R-WAVES HAD DIMINISHED TO 1.9 MV. THE LEAD WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
AFTER 1 MONTH OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED DUE TO AN INFECTION.
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/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |