FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 2983825
·
Received February 28, 2013
Report
- Report Number
- 2017865-2013-01566
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- January 23, 2013
- 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO A FOLLOW UP EXPERIENCING FATIGUE. THE RIGHT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND A DROP IN SENSING. A FLUOROSCOPY REVEALED THAT THE LEAD DISLODGED. THE LEADWAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88665 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |