FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1073209
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02022
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 9, 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
- NE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND AN ABRASION ON THE PROXIMAL INSULATION AT 20.1 CM FROM THE CONNECTOR PIN EXPOSING THE PROXIMAL COIL TO FRICTION WITH THE CAN. THIS WOULD CAUSE THE REPORTED PROBLEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE AND A SENSING ANOMALY.
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 | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |