FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1955722
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00802
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 26, 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 Location
- CA
- 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 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH INTERMITTENT CAPTURE AT 2.75 VOLTS. THE VENTRICULAR LEAD WAS REPOSITIONED AND THRESHOLD WAS AT LESS THAN EQUAL TO 1 VOLT BUT IN RECOVERY NON-CAPTURED BEATS WERE OBSERVED. 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/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | 5826, (B)(4) |