FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1955735
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00828
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- August 10, 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. OTHER TEXT : NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED ELEVATED THRESHOLD POST IMPLANT. THE LEAD WAS REPOSITIONED ON (B)(6) 2010, BUT AGAIN EXHIBITED ELEVATED THRESHOLD. AN EMERGENCY OPERATION WAS CONDUCTED DUE TO PACING FAILURE; THE LEAD WAS FOUND TO BE SECURELY POSITIONED. SEVERAL ATTEMPTS WERE MADE TO REPOSITION THE LEAD, HOWEVER AS THE IMPEDANCE MEASURED LESS THAN 200 OHMS AFTER REPOSITIONING, 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 | 1688TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |