FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1896318
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04976
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 21, 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
- CA
- 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 PRESENTED DUE TO FEELING POCKET SIMULATION. THE VENTRICULAR LEAD IMPEDANCE WAS LESS THAN 200 OHMS IN BOTH THE UIPOLAR AND BIPOLAR CONFIGURATIONS WHEN PROGRAMMED TO 4.0 V, 1.5 MS. R-WAVES COULD NOT BE SENSED AT 0.5 MV. NOISE WAS OBSERVED ON THE VENTRICULAR CHANNEL. THE LEAD WAS EXPLANTED 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 | 1688T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |