FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 4182231
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-03164
- Event Type
- Injury
- Date Received
- January 13, 2014
- 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
- IN, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RV LEAD WAS CAPPED BECAUSE IT HAD BEEN IMPLANTED TOO POSTERIOR. SENSING AND PACING WERE OF THE LEFT ATRIUM. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26409 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC. CRMD | 1488T/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |