FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1955498
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00858
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 1, 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
- ND
- 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
NEW INFORMATION NOTES THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2013. THE DEVICE WAS RECEIVED AT SJM ON (B)(4) 2013.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2010. AT THE POST OPERATIVE CHECK, IT WAS NOTED THAT THE ATRIAL LEAD EXHIBITED INCREASED CAPTURE THRESHOLD OF 5 V AT 0.6 MS AND DECREASED P-WAVE SENSING OF 0.7 MV.
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 | 1882TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |