FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 9629098
·
Received January 24, 2020
Report
- Report Number
- 2017865-2020-00953
- Event Type
- Injury
- Date Received
- January 24, 2020
- Date of Event
- January 8, 2020
- Report Date
- February 17, 2020
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- UDI-DI
- 05414734501705
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
MANUFACTURER REPORT NUMBER: 2017865-2019-17554, MANUFACTURER REPORT NUMBER: 2017865-2020-00952, MANUFACTURER REPORT NUMBER: 2017865-2020-00954. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE CAUSE OF THE INFECTION WAS NOT KNOWN. ALSO, THE RIGHT ATRIAL LEAD HAD ERODED THROUGH THE SKIN ON THE PATIENT¿S CHEST. THE PACEMAKER, RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD, AND PREVIOUSLY CAPPED RIGHT VENTRICULAR LEAD WERE EXPLANTED ON (B)(6) 2020. THE PATIENT WAS STABLE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89360 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1888TC/58 | 3494699 | 05414734501705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |