FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 2014109
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01518
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- November 23, 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 Location
- WA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS OF THE LEAD FOUND THAT THE DISTAL INSULATION WAS ABRADED/SEPARATED AND ALL FOUR WIRES OF THE DISTAL COIL WERE FRACTURED AT 17 CM FROM THE CONNECTOR PIN. THIS DAMAGE CAUSED THE REPORTED HIGH CAPTURE THRESHOLDS, HIGH IMPEDANCE AND NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED NOISE AND HIGH THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1788TC/40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |