FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 20073230
·
Received August 27, 2024
Report
- Report Number
- 2017865-2024-63581
- Event Type
- Injury
- Date Received
- August 27, 2024
- Date of Event
- August 7, 2024
- Report Date
- September 9, 2024
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- UDI-DI
- 05414734502887
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: B5 SECTION.
Description of Event or Problem · 0
IT WAS NOTED THE ATRIAL LEAD HAD DISLODGED. THE DISLODGEMENT OF THE LEAD WAS VERIFIED BY X-RAY. THE LEAD WAS EXPLANTED AND REUSED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Description of Event or Problem · 0
IT WAS NOTED THE ATRIAL LEAD HAD DISLODGED. THE DISLODGEMENT OF THE LEAD WAS VERIFIED BY X-RAY. THE LEAD WAS REPOSITIONED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1218816 | TENDRIL STS | NO MATCH | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/52 | P000205194 | 05414734502887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Male | Required Intervention | ASSURITY MRI PACEMAKER| TENDRIL LEAD |