FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1896444
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05124
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- June 7, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 THE ATRIAL LEAD EXHIBITED HIGH THRESHOLDS. AT THE LAST FOLLOW-UP THE P-WAVES SHOWED 2.1 MV AND PACING THRESHOLDS WERE AT 6.25, 0.5 MS. REPOSITIONING OF THE LEAD WAS NOT SUCCESSFULL AND WAS 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/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | 1158T/86, (B)(4) |