FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 15613013
·
Received October 16, 2022
Report
- Report Number
- 2938836-2022-00016
- Event Type
- Malfunction
- Date Received
- October 16, 2022
- Date of Event
- September 27, 2022
- Report Date
- November 9, 2022
- Manufacturer
- ABBOTT ELECTROPHYSIOLOGY
- Product Code
- NVN
- UDI-DI
- 05414734502870
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED EVENT OF LEAD DISLODGEMENT WAS NOT CONFIRMED. AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN ONE PIECE FOR ANALYSIS. FINAL ANALYSIS DID NOT IDENTIFY ANY ANOMALIES.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT PRESENTED DURING UNRELATED PROCEDURE. DURING PROCEDURE, THE PHYSICIAN ACCIDENTLY DISLODGED THE ATRIAL LEAD. THE REPORTED LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2224551 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ABBOTT ELECTROPHYSIOLOGY | 2088TC/46 | A000081913 | 05414734502870 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | ASSURITY MRI| MEDTRONIC RV LEAD |