FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1955797
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00713
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 19, 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
- NM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS RETURNED IN TWO PIECES. FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 2.9 CM FROM THE HELIX END, DUE TO FRICTION WITH ANOTHER DEVICE.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. A FRACTURE WAS SUSPECTED. 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 | 1488T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | (B)(4) |