FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 4191828
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04300
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- January 14, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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. VISUAL INSPECTION OF THE COMPLETE LEAD FOUND INSULATION DAMAGE WHICH WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED AFTER AN IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28320 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE, NVN | NVN | ST. JUDE MEDICAL, INC., CRMD | 1688TC/46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |