FDA Adverse Event
Malfunction
Summary report: N
TENDRILL STS
MDR report key: 4202298
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04958
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- July 15, 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
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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 LEAD DISLODGED WAS NOT CONFIRMED IN THE LABORATORY. THE LEAD WAS TESTED NORMALLY DURING THE ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD DISLODGED DURING IMPLANT. THE LEAD WAS NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29075 | TENDRILL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 1688TC/46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |