FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1223827
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03461
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE LEAD OUTER INSULATION WAS DAMAGED, DUE TO CLAVICULAR CRUSH AT 30 CM FROM THE DISTAL TIP ELECTRODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. LEAD IMPEDANCE WAS LESS THAN 200 OHMS. MUSCLE STIMULATION WAS ALSO NOTED.
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 | 1688T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |