FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 2014088
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01689
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 17, 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 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 FELT CHEST PAIN AND WENT TO THE HOSPITAL. IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED DURING REPOSITIONING OF THE VENTRICULAR LEAD. THE ATRIAL LEAD WAS ALSO REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention | 7171Q/58, (B)(4) |