FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1050476
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01277
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 11, 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
- FL
- 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 TO THE EMERGENCY ROOM COMPLAINING OF DIZZY SPELLS. THERE WAS INTERMITTENT LOSS OF VENTRICULAR CAPTURE IN THE BIPOLAR CONFIGURATION WHEN THE VENTRICULAR OUTPUT WAS PROGRAMMED TO 4.0 V. LEAD IMPEDANCE WAS 257 OHMS. THE LEAD WAS REPOSITIONED, BUT THE PATIENT STILL EXPERIENCED SYNCOPE. THEREFORE, THE LEAD WAS REPLACED. THE PATIENT WAS PACEMAKER DEPENDENT AND HAD BEEN SYMPTOMATIC FOR ONE YEAR.
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/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |