FDA Adverse Event
Malfunction
Summary report: N
TENDRILL STS
MDR report key: 4202302
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04951
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- May 16, 2011
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- Product Code
- NVN
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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. THE REPORTED FIELD EVENT OF UNACCEPTABLE THRESHOLD WAS NOT CONFIRMED. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE PATIENTS CHRONIC LEAD HAD HIGH THRESHOLD. THE PHYSICIAN ATTEMPTED TO REPLACE THE LEAD BUT COULD NOT OBTAIN BETTER THRESHOLDS. THE NEW WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29739 | TENDRILL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 1688TC/46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |