FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1955652
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00966
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 8, 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 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 WHILE THE PATIENT WAS AT THE HOSPITAL FOR UNRELATED REASONS, SHE STUMBLED, CAUSING THE VENTRICULAR LEAD TO DISLODGE. THE LEAD SHOWED ARTIFACTS AND AN INCREASE IN IMPEDANCE. WHEN THE POCKET WAS OPENED, IT WAS NOTED THAT THE LEAD HAD NOT BEEN PROPERLY FIXATED. THE INSULATION HAD BEEN SUTURED DIRECTLY, AS NO SUTURE SLEEVE WAS USED. 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 | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | (B)(4) |