FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1073468
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01983
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH APPARENT PERICARDIAL EFFUSION, BLOOD PRESSURE, AND HEART RATE PROBLEMS. THE LEAD WAS REPOSITIONED AND THE ECHOCARDIOGRAM SHOWED NO PERICARDIAL EFFUSION. AFTER THE REPOSITIONING, THE PATIENT'S CONDITION STABILIZED AND THE SYSTEM FUNCTIONED NORMALLY. SYSTEM FUNCTIONED NORMALLY.
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 | 61 YR | Required Intervention |