FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1050631
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01598
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- January 2, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- 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 POST IMPLANT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. IT WAS RESOLVED WITH AUTOCAPTURE TURNED OFF AND BIPOLAR PACING. THE PATIENT CONTINUED TO FEEL STIMULATION DESPITE ATTEMPTS TO PACE AT LOWER OUTPUTS. AN X-RAY CONFIRMED LEAD DISLODGEMENT OF BOTH LEADS. THE SUTURE AT TIEDOWN WAS LOST. THE LEADS WERE REPOSITIONED WITH NO FURTHER CONCERNS.
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 |