TENDRIL ST
Report
- Report Number
- 2017865-2019-14530
- Event Type
- Injury
- Date Received
- October 2, 2019
- Date of Event
- September 18, 2019
- Report Date
- November 5, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- UDI-DI
- 05414734501750
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
A PARTIAL LEAD WITH THE PIN MEASURING 4.5 CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
RELATED MANUFACTURER REFERENCE NUMBER: 201786-2019-14527. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATING ROOM FOR LEAD REVISION. THE PATIENT'S RIGHT VENTRICULAR LEAD HAD A HISTORY OF NOISE AND WAS BEING REPLACED. DURING PROCEDURE, THE PHYSICIAN NOTICED AN INSULATION BREACH ON THE RIGHT ATRIAL LEAD. THE LEADS WERE CAPPED ON 18 SEPTEMBER 2019 AND A PORTION OF THE LEAD WAS EXPLANTED. ONLY THE RIGHT VENTRICULAR LEAD WAS REPLACED. PATIENT WAS STABLE POST PROCEDURE.
NEW INFORMATION NOTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 941298 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1888TC/52 | 2870514 | 05414734501750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |