FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1050478
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01454
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 10, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- 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 THE VENTRICULAR LEAD EXHIBITED 205 OHMS IMPEDANCE IN THE UNIPOLAR CONFIGURATION. LOSS OF CAPTURE AT HIGH OUTPUTS WERE ALSO NOTED. LEAD IMPEDANCE IN BIPOLAR WAS 333 OHMS WITH A 5.5 V, 1.0 MS CAPTURE THRESHOLD. THE LEAD WAS REPOSITIONED, HOWEVER CAPTURE THRESHOLDS REMAINED HIGH. THE LEAD REMAINED IMPLANTED AND OUTPUTS WERE SET TO 7.0 V, 1.0 MS. THE PATIENT WOULD BE MONITORED.
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 | Required Intervention |