FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3801028
·
Received May 8, 2014
Report
- Report Number
- 2017865-2014-06928
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- September 28, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
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
NEW INFORMATION NOTES THE LEAD WAS EXPLANTED AND RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277617 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 1888TC/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |