FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3951260
·
Received July 22, 2014
Report
- Report Number
- 2017865-2014-02380
- Event Type
- Injury
- Date Received
- July 22, 2014
- Date of Event
- November 14, 2011
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- Product Code
- DTB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE WITH OVERSENSING. IT WAS CLINICALLY RESOLVED BY REPROGRAMMING. THE DEVICE REMAINED IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION INDICATES THE LEAD CONTINUES TO EXHIBIT OVERSENSING. THE LEAD WAS CAPPED AND REPLACED ON (B)(4) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428192 | TENDRIL ST | DTB | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 1888TC/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |