FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 2014097
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01711
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 15, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 ONE DAY POST IMPLANT, R-WAVES DECREASED FROM 7.5 MV TO 2.75 MV, VENTRICULAR LEAD IMPEDANCE WENT FROM 600 OHMS TO 490 OHMS AND THERE WAS INTERMITTENT LOSS OF VENTRICULAR CAPTURE AT 3.5 V, 1.0 MS. ON (B)(6) 2010, FLUOROSCOPY REVEALED RIGHT VENTRICULAR LEAD DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED AT THE RIGHT VENTRICULAR SEPTUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2088TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention |