FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 2014252
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01483
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- January 27, 2011
- 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
- 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 RIGHT VENTRICULAR LEAD EXHIBITED CAPTURE THRESHOLDS OF 4.0 V, 1.5 MS IN THE UNIPOLAR AND 4.5 V, 1.5 MS IN THE BIPOLAR CONFIGURATIONS. SENSING WAS 2.6 MV BUT THE PATIENT WAS IN A JUNCTIONAL RHYTHM AT THE TIME OF TESTING. THE LEAD WAS CAPPED AND REPLACED.
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 | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | (B)(4) |