FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 9324711
·
Received November 14, 2019
Report
- Report Number
- 2017865-2019-16472
- Event Type
- Injury
- Date Received
- November 14, 2019
- Date of Event
- November 5, 2019
- Report Date
- November 14, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- UDI-DI
- 05414734501705
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED ON 11/05/2019 DUE TO OVER-SENSING. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1116124 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1888TC/58 | 3080115 | 05414734501705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |